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

Kati Järvelä

Status and phase: Completed; Phase 4

Conditions: Fluid Volume Disorder

Treatments: Drug: NaCl 0.9%; Drug: 7.2% NaCl/hydroxyethylstarch

Study type: Interventional

Funder types: Other

Identifiers

NCT01348659

2010-019352-42 (EudraCT Number)

R09246M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

7.2% NaCl/hydroxyethyl starch

Active Comparator group

Description:

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

Treatment:

Drug: 7.2% NaCl/hydroxyethylstarch

0.9% NaCl

Active Comparator group

Description:

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

Treatment:

Drug: NaCl 0.9%