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

NCT ID: NCT01675453

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

7.2% NaCl /hydroxyethyl starch 200/0.5

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)

Group Type: ACTIVE_COMPARATOR

7.2% NaCl plus 6% hydroxyethyl starch 200/0.5

Intervention Type: DRUG

0.9% NaCl

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)

Group Type: PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type: DRUG

Interventions

7.2% NaCl plus 6% hydroxyethyl starch 200/0.5

Intervention Type: DRUG

0.9% NaCl

Intervention Type: DRUG

Other Intervention Names

HyperHAES; Saline

Eligibility Criteria

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%.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Evgeny Fominskiy, MD, PhD

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir V Lomivorotov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Novosibirsk Research Institute of Pathology of Circulation

Locations

Novosibirsk Research Institute of Pathology of Circulation

Novosibirsk, Novosibirsk Territory, Russia

Countries

Russia

References

Lomivorotov VV, Fominskiy EV, Efremov SM, Nepomniashchikh VA, Lomivorotov VN, Chernyavskiy AM, Shilova AN, Karaskov AM. Infusion of 7.2% NaCl/6% hydroxyethyl starch 200/0.5 in on-pump coronary artery bypass surgery patients: a randomized, single-blind pilot study. Shock. 2014 Mar;41(3):193-9. doi: 10.1097/SHK.0000000000000087.

Reference Type: DERIVED

PMID: 24549094 (View on PubMed)

Other Identifiers

ESHHS

Identifier Type: -

Identifier Source: org_study_id