CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Placebo 0.0025 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04312971
NCT04312971N/ACompleted

Effects of Norepinephrine Infusion During Cardiopulmonary Bypass on Perioperative Changes in Lactic Acid Level: A Randomized Controlled Study

Imam Abdulrahman Bin Faisal University·interventional·Posted Mar 18, 2020·Updated Dec 10, 2021

In Brief

A clinical study evaluating Placebo, Norepinephrine, and 2 other interventions for Cardiac Surgery and Cardiopulmonary Bypass. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

The primary objective is to test the efficacy and safety of the accuracy of continuous intravenous infusion of norepinephrine during cardiopulmonary bypass (CPB) on the prevention of hyperlactatemia after cardiac surgery. "Efficacy" would be tested with measurement of the postoperative changes in lactic acid level over time from the baseline value before induction of general anesthesia. "safety" would be tested with observing the post-cardiotomy need for inotropic and vasopressor support, the incidence of postoperative acute kidney injury (AKI), changes in cardiac troponin level (CnTnI), and signs of ischemic splanchnic injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 18, 2020
Enrollment StartMay 6, 2020
Primary CompletionApr 10, 2021
Study CompletionSep 20, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.3 years ago

Interventions

Placebodrug

Patients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of Normal Saline 0.9% with a starting dose of 0.0025 ml/kg/min.

Norepinephrinedrug

Patients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of norepinephrine (40 ug/ml) with a starting dose of 0.0025 ml/kg/min.

Increase infusion rateother

Infusion rate will be increased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min increments

Decrease infusion rateother

Infusion rate will be decreased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min decrements