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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Edema; Coronary Artery Disease

Treatments: Drug: 0.9% NaCl; Drug: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01675453

ESHHS

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass

Exclusion criteria

• age >70 years
• body mass index <18 and >35 kg/m2
• left ventricular ejection fraction <40%
• myocardial infarction <6 months before surgery
• stroke or transient ischemic attack <12 months before surgery
• diabetes mellitus
• glomerular filtration rate <90 mL/min
• emergency surgery
• hematocrit <30%.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

7.2% NaCl /hydroxyethyl starch 200/0.5

Active Comparator group

Description:

On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)

Treatment:

Drug: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5

0.9% NaCl

Placebo Comparator group

Description:

On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)

Treatment:

Drug: 0.9% NaCl