Trial | NCT01348659  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
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.
Study Started
May 31
2011
Primary Completion
May 31
2012
Study Completion
May 31
2012
Last Update
May 07
2012
Estimate

Drug 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.

  • Other names: Hyperhaes®, Fresenius Kabi

Drug NaCl 0.9%

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

  • Other names: Natriumklorid Braun 9 mg/ml

7.2% NaCl/hydroxyethyl starch Active Comparator

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

0.9% NaCl Active Comparator

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

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.
No Results Posted