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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fluid Volume Disorder

Intervention / Treatment
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* Drug: 7.2% NaCl/hydroxyethylstarch
* Drug: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7.2% NaCl/hydroxyethyl starch<br>250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) (Hyperhaes®, Fresenius Kabi) | Drug: 7.2% NaCl/hydroxyethylstarch<br>* 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.<br>* Other names: Hyperhaes®, Fresenius Kabi;|
| Active Comparator: 0.9% NaCl<br>250 ml of NaCl 0.9% (Natriumklorid Braun 9 mg/ml) | Drug: NaCl 0.9%<br>* 250 ml of NaCl 0.9% will be given into the venous reservoir of the CPB circuit after aortic declamping.<br>* Other names: Natriumklorid Braun 9 mg/ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in extracellular water from baseline to the first postoperative morning. | Perioperative fluid balance will be assessed by measuring changes in body weight and extracellular water from baseline to the first postoperative morning. | 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of fluids during the day of surgery. | Need of fluids and diuretic medication during the day of surgery until the first postoperative morning will be recorded. | 24h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertonic saline, Extracellular fluid, cardiopulmonary bypass