Effects of Hypertonic Saline-HES Solution on Extracellular Water in Cardiac Surgery Patients

NCT ID: NCT01348659

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-05-31

Brief Summary

The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning.

Detailed Description

Cardiac surgery and cardiopulmonary bypass (CPB) cause fluid retention in the body. Both dilution of serum proteins and destruction of vascular endothelial glycocalyx cause extravasation of the fluids. We cannot avoid this phenomenon but we can try to restore the excess fluid into the intravascular space where it can be excreted via the kidneys.

Hypertonic saline (HS) creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular space into the extracellular space and from the extravascular space into the intravascular space. The intravascular hypertonic benefit is short-lasting as a result of redistribution of fluid between the intravascular and interstitial spaces. The effect can be lengthened by adding colloid component into the solution.

The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning. Secondary endpoints are the need of fluids and diuretic medication during the perioperative period.

Conditions

Fluid Volume Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

7.2% NaCl/hydroxyethyl starch

250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) (Hyperhaes®, Fresenius Kabi)

Group Type: ACTIVE_COMPARATOR

7.2% NaCl/hydroxyethylstarch

Intervention Type: DRUG

250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) will be given into the venous reservoir of the cardiopulmonary bypass circuit after aortic declamping.

0.9% NaCl

250 ml of NaCl 0.9% (Natriumklorid Braun 9 mg/ml)

Group Type: ACTIVE_COMPARATOR

NaCl 0.9%

Intervention Type: DRUG

250 ml of NaCl 0.9% will be given into the venous reservoir of the CPB circuit after aortic declamping.

Interventions

7.2% NaCl/hydroxyethylstarch

250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) will be given into the venous reservoir of the cardiopulmonary bypass circuit after aortic declamping.

Intervention Type: DRUG

NaCl 0.9%

250 ml of NaCl 0.9% will be given into the venous reservoir of the CPB circuit after aortic declamping.

Intervention Type: DRUG

Other Intervention Names

Hyperhaes®, Fresenius Kabi; Natriumklorid Braun 9 mg/ml

Eligibility Criteria

Inclusion Criteria

• male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction < 40%).

Exclusion Criteria

• chronic hyponatremia and significant renal dysfunction.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Finnish Cultural Foundation

OTHER

Sponsor Role: collaborator

Kati Järvelä

OTHER

Sponsor Role: lead

Responsible Party

Kati Järvelä

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kati Järvelä, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital Heart Center

Locations

Tampere University Hospital Heart Center

Tampere, , Finland

Countries

Finland

Other Identifiers

2010-019352-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R09246M

Identifier Type: -

Identifier Source: org_study_id