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Clinical trial to compare two methods of giving intravenous fluid therapy during the operation in open abdominal surgeries

Comparative evaluation of pulse pressure variation guided goal directed fluid therapy with conventional intraoperative fluid therapy in exploratory laparotomies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033021
Enrollment
36
Registered
2021-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Goal Directed intraoperative fluid therapy: Intraoperative intravenous fluid administration guided by pulse pressure variation obtained on the Mindray monitor every 15 minutes during th

Sponsors

Department of Anesthesiology and Intensive Care Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients falling under the American Society of Anesthesiologists(ASA) physical status classes I, II, and III undergoing elective and emergency exploratory laparotomy under general anesthesia

Exclusion criteria

Exclusion criteria: 1. Pregnant patients 2. Preexisting ischemic or valvular heart disease, heart failure, or cardiac arrhythmias 3. Chronic kidney disease 4. Preexisting coagulopathies

Design outcomes

Primary

MeasureTime frame
Postoperative plasma lactate levelTimepoint: Postoperative plasma lactate level- 1 hour after the end of surgery

Secondary

MeasureTime frame
Intraoperative blood loss and perioperative blood transfusion requirement, estimated from the intraoperative change in hematocritTimepoint: 1. Baseline hematocrit- Preoperatively before induction of anesthesia 2. Postoperative hematocrit- 1 hour after the end of surgery;Intraoperative hemodynamic trends measured by 1. Mean arterial pressure trend during the intraoperative period 2. Number of hypotensive episodes 3. Vasopressor requirement and consumption: whether vasopressor required and if yes, the total consumption in the intraoperative period in micrograms.Timepoint: Mean arterial pressure recorded at baseline ( before induction of anesthesia) and then at 15 min intervals during the intraoperative period. Total number of hypotensive episodes and vasopressor requirement/consumption during the intraoperative period at the end of surgery;Intraoperative tissue perfusionTimepoint: 1. Baseline plasma lactate level- Preoperatively before induction of anesthesia 2. hourly plasma lactate levels measured intraoperatively;Post-operative outcomes and complications 1. Need for postoperative mechanical ventilation 2. Return of bowel motility will be assessed by time till passage of first flatus 3. Postoperative pulmonary involvement 4. Incidence of wound dehiscence, anastomotic leakage or re-exploration Timepoint: They will be assessed at the end of surgery;Postoperative pulmonary, renal, hepatic and coagulation functions 1. Pulmonary function: Change in PaO2:FiO2 ratio measured from arterial blood gas analysis 2. Renal function: Intraoperative urine output(ml), postoperative serum creatinine(mg/dl) compared to preoperative baseline, post operative fractional excretion of sodium(%) 3. Hepatic function: Postoperative transaminase levels(SGPT and SGOT in IU) compared to preoperative baseline 4. Coagulation function: Postoperative INRTimepoint: PaO2:FiO2 ratio: 1. Baseline 2. 1 hour postoperatively Intraoperative urine output: Hourly dur

Countries

India

Contacts

Public ContactDr Arshi Agrawal

Maulana Azad Medical College

dramitkohli@yahoo.com9818073402

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026