Effects of Hypertonic Saline-HES Solution on Extracellular Water in Cardiac Surgery Patients
|Fluid Volume Disorder||Drug: 7.2% NaCl/hydroxyethylstarch Drug: NaCl 0.9%||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Hypertonic Saline-hydroxyethyl Starch Solution on Extracellular Water in Cardiac Surgery Patients|
- Change in extracellular water from baseline to the first postoperative morning. [ Time Frame: 24h ]Perioperative fluid balance will be assessed by measuring changes in body weight and extracellular water from baseline to the first postoperative morning.
- Need of fluids during the day of surgery. [ Time Frame: 24h ]Need of fluids and diuretic medication during the day of surgery until the first postoperative morning will be recorded.
|Study Start Date:||May 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 7.2% NaCl/hydroxyethyl starch
250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) (Hyperhaes®, Fresenius Kabi)
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 Name: Hyperhaes®, Fresenius Kabi
Active Comparator: 0.9% NaCl
250 ml of NaCl 0.9% (Natriumklorid Braun 9 mg/ml)
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 Name: Natriumklorid Braun 9 mg/ml
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348659
|Tampere University Hospital Heart Center|
|Tampere, Finland, 33521|
|Principal Investigator:||Kati Järvelä, MD, PhD||Tampere University Hospital Heart Center|