- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04785755
Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites
Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Egyptian Cirrhotic Patients With Ascites
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This comparative, randomized, prospective controlled clinical trial was conducted on 90 cirrhotic patients with ascites who were admitted to the Hepatology Department of National Liver Institute, Menoufiya University. The study was approved by the Institution Review Board (IRB) of the National Liver Institute (NLI), Menoufiya University, Egypt with NLI/IRB protocol number: 00131/2017. Informed consent was obtained from all patients who participated in the study.
Patients were randomized into four groups:
Group I: (n=15) received oral standard diuretic therapy (furosemide 40 mg plus spironolactone 100 mg with dose increase in 40 mg :100 mg ratio).
Group II: (n=25) received (150 ml,1.4% - 4.6%) of hypertonic saline solution (HSS) plus standard diuretics therapy.
Group III: (n=25) received etilefrine 5 mg tablets 3 times daily plus standard diuretics therapy.
Group IV: (n=25) received (150 ml, 1.4% - 4.6%) of HSS and etilefrine 5 mg tablets 3 times daily plus standard diuretics therapy.
Time frame:
Oral standard diuretics therapy administered for 38 days. Etilefrine tablets administered for 38 days. Infusion of HSS administered for eight days. Diuretics dosage reassessed according to blood pressure, diuresis, serum sodium, and serum potassium levels.
All blood and urine samples were collected and measured as follows:
- At baseline before initiation of any treatment (first measurement)
- Eight days after treatment with studied medications (second measurement).
- One month after the second measurement (third measurement).
Samples collection:
Venous blood samples were drawn from enrolled patients in the morning before treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement). Blood samples were centrifuged and the resulting supernatant was frozen at -80 C until all samples were collected. 24-hr urine was collected in the morning from 7 am to 7 am of the next day before initiation of treatment, after eight days of treatment, and after a month from the second measurement to assess diuresis and urinary creatinine, urinary Na, and urinary K, also hepatic and renal functions, complete blood count, serum levels of c-reactive protein, interleukin-6, aldosterone, and leptin were measured at baseline, after eight days and, after a month from the second measurement.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Menoufiya
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Shibīn Al Kawm, Menoufiya, Egypt, 32511
- National liver institute- menoufiya university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All cirrhotic patients with ascites grade I- III.
- Patients ages from 25 -65 years.
Exclusion Criteria:
- Non-cirrhotic ascites.
- Congestive heart failure.
- Acute renal failure.
- Hepatocellular carcinoma.
- All Cancer types.
- Arterial hypertension.
- Acute infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group I
The control group (n=15) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
|
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Other Names:
|
EXPERIMENTAL: Group II
The hypertonic saline solution (HSS) group (n=25) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the start of the study to the end of the study) with hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
|
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Other Names:
Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
Other Names:
|
EXPERIMENTAL: Group III
The etilefrine group (n=25) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study), and etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
|
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Other Names:
Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Other Names:
|
EXPERIMENTAL: Group IV
The hypertonic saline solution (HSS) + Etilefrine group (n=25) received oral standard diuretic therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg100mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study), with hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days, and etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
|
Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
Other Names:
Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
Other Names:
Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate and compare the impact of adding hypertonic saline solution (HSS) infusion and/or etilefrine to oral standard diuretics therapy on the inflammatory pathway in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum interleukin-6 (pg/ml) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the impact of adding HSS infusion and/or etilefrine to oral standard diuretics therapy on the serum C-reactive protein in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum C-reactive protein (mg/L) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral standard diuretics therapy on the metabolic pathway in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum leptin (pg/ml) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the impact of adding HSS solution infusion and/or etilefrine to oral standard diuretics therapy on the renal hemodynamics in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in plasma aldosterone (pg/ml) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the impact of adding HSS infusion and/or etilefrine to oral diuretics therapy on the diuresis of cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in 24-hour urine output (ml/24 hr) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
24-hr urine was collected in the morning from 7 am to 7 am of the next day before treatment (first collection), after eight days of treatment (second collection), and after a month from the second collection for assessing diuresis.
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to oral diuretics therapy on the systemic hemodynamic of cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the effects of the treatments on mean arterial pressure (MAP) in patients with ascites.
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) were measured using a sphygmomanometer to calculate MAP first on day one of the treatments (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
Final changes in MAP (mmHg) were calculated from the first day of the study to the end of the study (study duration 38 days)
|
38 days (from the first day of the study to the end of the study)
|
Evaluate the effect of adding HSS infusion and/or etilefrine to oral diuretics therapy on serum sodium (Na) concentration in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum Na concentration (mEq/L) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate the effect of adding HSS infusion and/or etilefrine to oral diuretics therapy on serum creatinine concentration in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum creatinine concentration (mg/dl) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the effect of adding HSS infusion and/or etilefrine to oral diuretics therapy on prothrombin concentration in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in prothrombin concentration (%) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to oral diuretics therapy on the model of end-stage liver disease (MELD score)in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By calculating the final change in MELD score in patients with ascites to assess the severity of liver disease for transplant planning, from the first day of the study to the end of the study (study duration 38 days).
MELD score calculation depends on serum creatinine, serum bilirubin, prothrombin time, and the score calculated by a suitable online medical calculator.
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on the model of end-stage liver disease depending on sodium (MELD score-Na)in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By calculating the final change in MELD-Na score in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
MELD-Na score calculation depends on serum creatinine, serum bilirubin, serum Na, prothrombin time, and the score calculated by a suitable online medical calculator.
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to oral diuretics therapy on Child-Pugh score in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By calculating the final change in Child-Pugh score in patients with ascites to assess the prognosis in liver cirrhosis from the first day of the study to the end of the study (study duration 38 days).
Child-Pugh score calculation depends on serum albumin, serum bilirubin, prothrombin time, ascites, and encephalopathy grades.
The score was calculated by a suitable online medical calculator.
All blood samples were collected for measuring from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on the bodyweight in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By calculating the final change in the patients' weight (kg) from the first day of the study to the end of the study (study duration 38 days).
All enrolled patients were weighed by suitable weight scale on the morning of the first day of the study (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on urinary sodium excretion in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in urinary Na concentration (mEq/24 hr) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
Urinary Na concentration was measured from a 24-hr urine collection sample.
24-hr urine was collected in the morning from 7 am to 7 am of the next day before initiation of the treatment (first measurement), after eight days of the treatment (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on urinary creatinine excretion in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in urinary creatinine concentration (mg/dl) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
24-hr urine collected in the morning from 7 AM to 7 AM of the next day before initiation of the study to measure urinary creatinine concentration (first measurement), after eight days of treatment (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on serum alanine aminotransferase enzyme (ALT) in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum ALT (U/L) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on serum albumin in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum albumin (mg/dl) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on serum total bilirubin in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum total bilirubin (mg/dl) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on serum blood urea nitrogen (BUN) in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in serum BUN (mg/dl) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Evaluate and compare the effect of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy on hemoglobin concentration in cirrhotic patients with ascites.
Time Frame: 38 days (from the first day of the study to the end of the study)
|
By measuring the final change in hemoglobin concentration (gm/dl) in patients with ascites from the first day of the study to the end of the study (study duration 38 days).
All blood samples were collected from enrolled patients in the morning on the first day of treatment (first measurement), after eight days (second measurement), and after a month from the second measurement (third measurement).
|
38 days (from the first day of the study to the end of the study)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy in cirrhotic patients with ascites.
Time Frame: 38 days (from the start of the study to the end of the study).
|
Assessed by the number of patients who developed any new episodes of spontaneous bacterial peritonitis (SBP), new onset of hepatic encephalopathy (HE), the incidence of gastrointestinal bleeding, the incidence of hepatorenal syndrome (HRS), or renal impairment (increase in serum creatinine > 50% above the baseline.
All assessments of enrolled patients were reported in the safety sheets.
|
38 days (from the start of the study to the end of the study).
|
Tolerability of adding HSS infusion and/or etilefrine to the standard oral diuretics therapy in cirrhotic patients with ascites.
Time Frame: 38 days (from the start of the study to the end of the study).
|
Assessed by the number of patients who developed any unwanted side effects were reported from the treatment regimen as osmotic demyelination syndrome (ODS), vein extravasation, hypokalemia, acute hypotension, and laboratory abnormalities.
All assessments of enrolled patients were reported in tolerability sheets.
|
38 days (from the start of the study to the end of the study).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gamal A Badra, professor, national liver institute / menoufiya university
- Study Director: Sahar El-Haggar, professor, Tanta University
- Study Director: hala El said, professor, national liver institute / menoufiya university
Publications and helpful links
General Publications
- Reynolds TB. Ascites. Clin Liver Dis. 2000 Feb;4(1):151-68, vii. doi: 10.1016/s1089-3261(05)70101-x.
- Gu XB, Yang XJ, Zhu HY, Xu BY. Effect of a diet with unrestricted sodium on ascites in patients with hepatic cirrhosis. Gut Liver. 2012 Jul;6(3):355-61. doi: 10.5009/gnl.2012.6.3.355. Epub 2012 Jul 12.
- Morando F, Rosi S, Gola E, Nardi M, Piano S, Fasolato S, Stanco M, Cavallin M, Romano A, Sticca A, Caregaro L, Gatta A, Angeli P. Adherence to a moderate sodium restriction diet in outpatients with cirrhosis and ascites: a real-life cross-sectional study. Liver Int. 2015 May;35(5):1508-15. doi: 10.1111/liv.12583. Epub 2014 May 21.
- Sam J, Nguyen GC. Protein-calorie malnutrition as a prognostic indicator of mortality among patients hospitalized with cirrhosis and portal hypertension. Liver Int. 2009 Oct;29(9):1396-402. doi: 10.1111/j.1478-3231.2009.02077.x. Epub 2009 Jul 7.
- Eghtesad S, Poustchi H, Malekzadeh R. Malnutrition in liver cirrhosis:the influence of protein and sodium. Middle East J Dig Dis. 2013 Apr;5(2):65-75.
- Arroyo V, Fernandez J. Relationship between systemic hemodynamics, renal dysfunction, and fluid retention in cirrhosis. Clin Liver Dis (Hoboken). 2013 Jun 21;2(3):120-122. doi: 10.1002/cld.185. eCollection 2013 Jun. No abstract available.
- Guo TT, Yang Y, Song Y, Ren Y, Liu ZX, Cheng G. Effects of midodrine in patients with ascites due to cirrhosis: Systematic review and meta-analysis. J Dig Dis. 2016 Jan;17(1):11-9. doi: 10.1111/1751-2980.12304.
- Singh V, Dhungana SP, Singh B, Vijayverghia R, Nain CK, Sharma N, Bhalla A, Gupta PK. Midodrine in patients with cirrhosis and refractory or recurrent ascites: a randomized pilot study. J Hepatol. 2012 Feb;56(2):348-54. doi: 10.1016/j.jhep.2011.04.027. Epub 2011 Jul 13.
- Hatanaka E, Shimomi FM, Curi R, Campa A. Sodium chloride inhibits cytokine production by lipopolysaccharide-stimulated human neutrophils and mononuclear cells. Shock. 2007 Jan;27(1):32-5. doi: 10.1097/01.shk.0000238061.69579.a5.
- Kolsen-Petersen JA. Immune effect of hypertonic saline: fact or fiction? Acta Anaesthesiol Scand. 2004 Jul;48(6):667-78. doi: 10.1111/j.1399-6576.2004.00396.x.
- Perez-Perez A, Vilarino-Garcia T, Fernandez-Riejos P, Martin-Gonzalez J, Segura-Egea JJ, Sanchez-Margalet V. Role of leptin as a link between metabolism and the immune system. Cytokine Growth Factor Rev. 2017 Jun;35:71-84. doi: 10.1016/j.cytogfr.2017.03.001. Epub 2017 Mar 4.
- Buechler C, Haberl EM, Rein-Fischboeck L, Aslanidis C. Adipokines in Liver Cirrhosis. Int J Mol Sci. 2017 Jun 29;18(7):1392. doi: 10.3390/ijms18071392.
- Reynolds TB, Lieberman FL, Goodman AR. Advantages of treatment of ascites without sodium restriction and without complete removal of excess fluid. Gut. 1978 Jun;19(6):549-53. doi: 10.1136/gut.19.6.549.
- Lafreniere G, Beliveau P, Begin JY, Simonyan D, Cote S, Gaudreault V, Israeli Z, Lavi S, Bagur R. Effects of hypertonic saline solution on body weight and serum creatinine in patients with acute decompensated heart failure. World J Cardiol. 2017 Aug 26;9(8):685-692. doi: 10.4330/wjc.v9.i8.685.
- Henriksen JH, Fuglsang S, Bendtsen F, Moller S. Arterial hypertension in cirrhosis: arterial compliance, volume distribution, and central haemodynamics. Gut. 2006 Mar;55(3):380-7. doi: 10.1136/gut.2005.064329.
- Li H, Guo Z, Yang X, Sun D. Mean arterial pressure drop is an independent risk factor of death in patients with HBV-related cirrhosis ascites. Turk J Gastroenterol. 2017 Jan;28(1):26-30. doi: 10.5152/tjg.2016.0412. Epub 2016 Dec 19.
- Drazner MH, Palmer BF. Hypertonic saline: a novel therapy for advanced heart failure? Am Heart J. 2003 Mar;145(3):377-9. doi: 10.1067/mhj.2003.165. No abstract available.
- Tuttolomondo A, Di Raimondo D, Bellia C, Clemente G, Pecoraro R, Maida C, Simonetta I, Vassallo V, Di Bona D, Gulotta E, Ciaccio M, Pinto A. Immune-Inflammatory and Metabolic Effects of High Dose Furosemide plus Hypertonic Saline Solution (HSS) Treatment in Cirrhotic Subjects with Refractory Ascites. PLoS One. 2016 Dec 12;11(12):e0165443. doi: 10.1371/journal.pone.0165443. eCollection 2016.
- Okuhara Y, Hirotani S, Naito Y, Nakabo A, Iwasaku T, Eguchi A, Morisawa D, Ando T, Sawada H, Manabe E, Masuyama T. Intravenous salt supplementation with low-dose furosemide for treatment of acute decompensated heart failure. J Card Fail. 2014 May;20(5):295-301. doi: 10.1016/j.cardfail.2014.01.012. Epub 2014 Jan 22.
- Haberl J, Zollner G, Fickert P, Stadlbauer V. To salt or not to salt?-That is the question in cirrhosis. Liver Int. 2018 Jul;38(7):1148-1159. doi: 10.1111/liv.13750. Epub 2018 May 16.
- Tuttolomondo A, Pinto A, Di Raimondo D, Corrao S, Di Sciacca R, Scaglione R, Caruso C, Licata G. Changes in natriuretic peptide and cytokine plasma levels in patients with heart failure, after treatment with high dose of furosemide plus hypertonic saline solution (HSS) and after a saline loading. Nutr Metab Cardiovasc Dis. 2011 May;21(5):372-9. doi: 10.1016/j.numecd.2009.10.014. Epub 2010 Mar 25.
- Gauthier A, Levy VG, Quinton A, Michel H, Rueff B, Descos L, Durbec JP, Fermanian J, Lancrenon S. Salt or no salt in the treatment of cirrhotic ascites: a randomised study. Gut. 1986 Jun;27(6):705-9. doi: 10.1136/gut.27.6.705.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Ascites
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Natriuretic Agents
- Cardiotonic Agents
- Membrane Transport Modulators
- Hormone Antagonists
- Adrenergic beta-Agonists
- Sympathomimetics
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Adrenergic beta-1 Receptor Agonists
- Vasoconstrictor Agents
- Sodium Potassium Chloride Symporter Inhibitors
- Pharmaceutical Solutions
- Spironolactone
- Furosemide
- Diuretics
- Etilefrine
Other Study ID Numbers
- ascites of liver cirrhosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatic Ascites
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University of AlbertaBecton, Dickinson and CompanyCompleted
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Healthgen Biotechnology Corp.Completed
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Protgen LtdCompletedHepatic AscitesChina
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Alexandria UniversityCompleted
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Sang Gyune KimEnrolling by invitationAscites HepaticKorea, Republic of
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Postgraduate Institute of Medical Education and...RecruitingCirrhosis | Ascites HepaticIndia
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Nina KimerTerminatedCirrhosis | Ascites Hepatic | Ascites (Non-Malignant)Denmark
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Montefiore Medical CenterWithdrawnLiver Cirrhosis | Ascites Hepatic
Clinical Trials on Oral standard diuretics therapy
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Paul Breslin, PhDThe Gerber FoundationNot yet recruitingAcute Gastroenteritis
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Nicklaus Children's Hospital f/k/a Miami Children...Einsoff BiohealthTerminatedDehydration | Acute GastroenteritisUnited States
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University Medical Center GroningenCompletedOverweight | Healthy Volunteers | Age Group: 60-70Netherlands
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St. Joseph's Hospital and Medical Center, PhoenixLund UniversityCompletedOral Hygiene | Ventilator Associated PneumoniaUnited States
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Wake Forest University Health SciencesCompletedHead and Neck Cancer | Radiation Toxicity | Radiation-Induced Xerostomia | Oral Complications of Chemotherapy and Head/Neck RadiationUnited States
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University of MalayaNot yet recruitingHead and Neck CancerMalaysia
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University of ParmaAzienda Ospedaliero-Universitaria di Parma; Azienda Unità Sanitaria Locale... and other collaboratorsNot yet recruiting
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Castilla-La Mancha Health ServiceComplejo Hospitalario La Mancha CentroCompletedSubacromial Impingement Syndrome | Vojta TherapySpain
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Université de MontréalSt. Justine's HospitalUnknownObstructive Sleep ApneaCanada
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Institute of Cardiology, Warsaw, PolandUnknownCardiac RehabilitationPoland