- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04775576
Comparison of Conventional Fluid Management Protocol With Targeted Pleth Variability Index (PVI) Monitoring Protocol During Total Abdominal Hysterectomy and Bilateral Salpingooferectomy Operation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intraoperative fluid management is very important in terms of postoperative organ perfusion and complications. While various complications such as acute renal failure, hypotension, arrhythmia, anastomotic leakage can be seen due to intraoperative hypovolemia; Hypervolemia can cause pulmonary edema, postoperative pneumonia, prolonged mechanical ventilation need, delayed wound healing, gastrointestinal system (GIS) edema and decreased intestinal motility.
Increasing the quality of intraoperative fluid therapy is a situation that may affect the morbidity and mortality of patients due to all these reasons.
Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively. Studies related to SpHb, which provides noninvasive continuous hemoglobin monitoring in accordance with pulse oximetry, show that there is a decrease in blood product transfusion compared to cases managed with conventional laboratory follow-up.
Our primary goal is to compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.
For this purpose, we aim to compare the amount of crystalloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols. Our secondary aim will be to compare the length of stay in the hospital.
The study is planned as a single center, prospective, randomized controlled clinical study. It was aimed to evaluate fluid therapy during elective total abdominal hysterectomy and bilateral salpingooferectomy operation. Before the operation, patients will be divided into 2 groups randomly. For randomization, the automatic system on the randomization.com website will be used. All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation. Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done. In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation. After two minutes of preoxygenation, anesthesia induction will be started. Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl. Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation. Initially, all patients will be given 250 ml intravenous crystalloid. Then 8-10 ml / kg / hour iv fluid maintenance will be started for the control group. If the mean arterial pressure (MAP) is <65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started. Patients in the PVI group will be started on maintenance fluid therapy at 2-3 ml / kg / hour. In addition to standard monitoring, if PVI is <13% and OAB≥65mmHg in measurements made with PVI, current fluid therapy will continue. If PVI is <13% and MAP <65 mmHg, noradrenaline infusion will be started. If PVI is> 13% and OAB≥65 mmHg, 250 ml iv colloid bolus will be administered, and iv colloid bolus will be continued until the PVI is <13% in the 5-minute follow-ups. If PVI> 13% and MAP <65 mmHg, patients should receive 250 ml i.v. colloid infusion will be given, if MAP <65mmHg continues in 5 minutes follow-up, 250 ml i.v. Colloid and noradrenaline infusion will be started and repeated until the OAB≥65 mmHg and PVI <13%. The decision to transfuse in both groups will be taken under the guidance of the European Society of Anesthesia (ESA) perioperative bleeding management guidelines. In the control group, hemorrhage will be monitored with laboratory Hb values, while SpHb and laboratory Hb values will be evaluated together in the PVI group.
Patients in the ASA1-2-3 risk group who will undergo elective total abdominal hysterectomy and bilateral salpingo-oophorectomy under general anesthesia, between the ages of 18-65, will be included in this study. The study will be conducted with 80 people.
In both groups, continuous arterial blood pressure, heart rate, oxygen saturation and arterial blood gas, lactate concentration at hourly intervals, hemoglobin, hematocrit, serum urea, creatinine, sodium, potassium, chlorine values, hospital stay, hourly intervals, intraoperative hourly and postoperatively 24 hours later, The amount of crystalloids and blood products used intraoperatively, postoperative volume dependent complications and their frequency will be evaluated.
The study will be conducted by anesthesiologists in the operating rooms located in the central campus of our hospital.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey, 34865
- Kartal Dr. Lütfi Kırdar City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Total abdominal hysterectomy and bilateral salpingooferectomy operation is planned Patients in the ASA 1-2-3 group
Exclusion Criteria:
Under 18 years old Severe cardiac arrhythmia Ejection fraction ≤ 30% Acute and / or chronic renal failure Patients who need more than 8ml / kg tidal volume due to advanced stage COPD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
This group will have fluid theraphy due to conventional methods.
The participants in this group will have 8-10 ml/kg/hour cristalloid infusion.
If the mean arterial pressure (MAP) is <65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied.
If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.
|
8-10 ml / kg / hour iv fluid maintenance will be started for the control group.
If the mean arterial pressure (MAP) is <65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied.
If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.
All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation.
Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done.
In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation.
After two minutes of preoxygenation, anesthesia induction will be started.
Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl.
Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation.
|
Active Comparator: Group 2
Patients in the PVI group will be started on maintenance fluid therapy at 2-3 ml / kg / hour.
In addition to standard monitoring, if PVI is <13% and OAB≥65mmHg in measurements made with PVI, current fluid therapy will continue.
If PVI is <13% and MAP <65 mmHg, noradrenaline infusion will be started.
If PVI is> 13% and OAB≥65 mmHg, 250 ml iv colloid bolus will be administered, and iv colloid bolus will be continued until the PVI is <13% in the 5-minute follow-ups.
If PVI> 13% and MAP <65 mmHg, patients should receive 250 ml i.v.
colloid infusion will be given, if MAP <65mmHg continues in 5 minutes follow-up, 250 ml i.v.
Colloid and noradrenaline infusion will be started and repeated until the OAB≥65 mmHg and PVI <13%.
|
All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation.
Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done.
In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation.
After two minutes of preoxygenation, anesthesia induction will be started.
Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl.
Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation.
Conventional fluid management is widely used in clinical practice.
In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition.
In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare the control group (conventional fluid management) with the PVI group (Pleth Variability Index and SpHb guided targeted fluid management) protocol.
Time Frame: 0-180 minute
|
compare the amount of crystalloids,colloids and blood products, blood lactate, serum creatinine and electrolyte levels applied in the intraoperative period as a result of both protocols.
|
0-180 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative length of stay in hospital
Time Frame: 24 hours
|
Evaluation of postoperative hospital stay in both groups
|
24 hours
|
Postoperative kidney injury
Time Frame: 24 hours
|
Present of postoperative kidney injury/failure
|
24 hours
|
Postoperative Lung complications
Time Frame: 24 hours
|
Present of hypervolemia related lung edema
|
24 hours
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8.
- Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.
- Holte K, Sharrock NE, Kehlet H. Pathophysiology and clinical implications of perioperative fluid excess. Br J Anaesth. 2002 Oct;89(4):622-32. doi: 10.1093/bja/aef220. No abstract available.
- Raikhel M. Accuracy of noninvasive and invasive point-of-care total blood hemoglobin measurement in an outpatient setting. Postgrad Med. 2012 Jul;124(4):250-5. doi: 10.3810/pgm.2012.07.2584.
- Doherty M, Buggy DJ. Intraoperative fluids: how much is too much? Br J Anaesth. 2012 Jul;109(1):69-79. doi: 10.1093/bja/aes171. Epub 2012 Jun 1.
- Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. doi: 10.1378/chest.115.5.1371.
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
Other Study ID Numbers
- 2020/514/172/4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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