CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 +1 moredrug
Likely dose
Not stated in 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/NCT01675453
NCT01675453Phase 2Completed

The Efficacy and Safety of 7.2% NaCl Plus 6% Hydroxyethyl 200/0.5 in Patients Scheduled for First-time Coronary Artery Bypass Grafting With Cardiopulmonary Bypass.

Meshalkin Research Institute of Pathology of Circulation·interventional·Posted Aug 30, 2012·Updated May 27, 2016

In Brief

A Phase 2 clinical trial evaluating 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 and 0.9% NaCl for Coronary Artery Disease and Edema. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes. Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment. The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2012
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.8 years ago

Interventions

7.2% NaCl plus 6% hydroxyethyl starch 200/0.5drug

0.9% NaCldrug