Clinical trial NCT01348659: Effects of Hypertonic Saline-HES Solution on Extracellular Water in Cardiac Surgery Patients
Official title: Effects of Hypertonic Saline-hydroxyethyl Starch Solution on Extracellular Water in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fluid Volume Disorder
Keywords: Hypertonic saline
Extracellular fluid
cardiopulmonary bypass
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Finnish Cultural Foundation
First posted: 2011-05-05
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in extracellular water from baseline to the first postoperative morning.
timeFrame: 24h
Secondary outcomes:
measure: Need of fluids during the day of surgery.
timeFrame: 24h
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital Heart Center
Study officials:
affiliation: Tampere University Hospital Heart Center
name: Kati Järvelä, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: