NCT01675453

The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Edema

Interventions

Type	Name	Description
DRUG	7.2% NaCl plus 6% hydroxyethyl starch 200/0.5
DRUG	0.9% NaCl

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-08-30
• Last updated: 2016-05-27
• Results posted: 2014-06-19

Locations

1 site across 1 country: Russia