- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520804
Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function
Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)** from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7.
α risk of 0.05, Statistical power of 80%
Sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ranistha Ratanarat, MD
- Phone Number: 66896685287
- Email: Ranittha@hotmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Recruiting
- Mahidol University
-
Contact:
- Ranistha Rattanarat, MD
- Phone Number: 0896685287
- Email: Ranittha@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Shock patients (hypotension with signs of poor tissue perfusion)
Exclusion Criteria:
- Age < 18 yr
- Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) < 35%),
- Prolong shock >24 hrs,
- Received chloride rich crystalloid (0.9% saline) or chloride rich colloid > 1000 ml within 72 hrs before recruitment
- Do-not-resuscitation patients,
- Contraindication for IV fluid administration such as pulmonary edema.,
- Stage V chronic kidney disease (CKD),
- chronic Hemodialysis or Peritonealdialyse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: normal saline
normal saline for fluid resuscitation and maintenance for 72 hours
|
Normal saline for shock patients in the first 72 hours
|
Experimental: sterofundin
sterofundin for fluid resuscitation and maintenance for 72 hours
|
sterofundin for shock patients in the first 72 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute kidney injury
Time Frame: 7 day
|
Number of Participants with acute kidney injury divided by KIDNEY DISEASE | IMPROVING GLOBAL OUTCOMES (KDIGO) Staging
|
7 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Requirement of Renal replacement therapy (RRT)
Time Frame: up to 7 day
|
up to 7 day
|
|
sodium level
Time Frame: day 1-3
|
change from baseline
|
day 1-3
|
potassium level
Time Frame: day 1-3
|
change from baseline
|
day 1-3
|
chloride level
Time Frame: day 1-3
|
change from baseline
|
day 1-3
|
bicarbonate level
Time Frame: day 1-3
|
change from baseline
|
day 1-3
|
28-day mortality
Time Frame: 28 days after admission
|
Number of Participants death within 28 day after admission
|
28 days after admission
|
ICU mortality
Time Frame: ICU admission up to 28 day
|
Number of Participants death at ICU within 28 day after admission
|
ICU admission up to 28 day
|
hospital stay
Time Frame: during hospital admission up to 28 day
|
number of Hospital admission date
|
during hospital admission up to 28 day
|
ICU hospital stay
Time Frame: during admission up to 28 day
|
number of Hospital admission date
|
during admission up to 28 day
|
mean arterial pressure
Time Frame: day1-3
|
mmHg (average)
|
day1-3
|
dose of norepinephrine
Time Frame: day1-3
|
(µg/k/min)
|
day1-3
|
dose of adrenaline
Time Frame: day1-3
|
(µg/k/min)
|
day1-3
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ranistha Ratanarat, MD, Mahidol University
Publications and helpful links
General Publications
- Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
- Barber AE, Shires GT. Cell damage after shock. New Horiz. 1996 May;4(2):161-7.
- Kristensen SR. Mechanisms of cell damage and enzyme release. Dan Med Bull. 1994 Sep;41(4):423-33.
- Kumar A, Parrillo J. Shock: Classification,Pathophysiology, and Approach to Management. In: Dellinger R, Parillo J,eds. Critical Care Medicine: Principles of Diagnosis and Management in the Adult. Philadelphia: Mosby Elsevier,2008.
- Marino PL.Inflammatory shock syndrome. In:Marino PL,eds. Marino's The ICU Book 4th edition.Philadelphia:Wolters Kluwer,2014.
- Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.
- Martini WZ, Cortez DS, Dubick MA. Comparisons of normal saline and lactated Ringer's resuscitation on hemodynamics, metabolic responses, and coagulation in pigs after severe hemorrhagic shock. Scand J Trauma Resusc Emerg Med. 2013 Dec 11;21:86. doi: 10.1186/1757-7241-21-86.
- Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72. Erratum In: Ann Surg. 2013 Dec;258(6):1118.
- Guidet B, Soni N, Della Rocca G, Kozek S, Vallet B, Annane D, James M. A balanced view of balanced solutions. Crit Care. 2010;14(5):325. doi: 10.1186/cc9230. Epub 2010 Oct 21.
- Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27. Erratum In: N Engl J Med. 2012 Aug 2;367(5):481.
- Ratanarat R, Hantaweepant C, Tangkawattanakul N, Permpikul C. The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification. J Med Assoc Thai. 2009 Mar;92 Suppl 2:S61-7.
- Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.
- Kidney disease: Improving Global outcomes (KDIGO) Acute kidney injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney injury.Kidney inter., Suppl.2012;2:1-138
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si566/2014
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