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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Volume Disorder
• Intervention / Treatment: Drug: 7.2% NaCl/hydroxyethylstarch; Drug: NaCl 0.9%

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Natriumklorid Braun 9 mg/ml

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kati Järvelä
• Collaborators: Finnish Cultural Foundation
• Investigators: Principal Investigator: Kati Järvelä, MD, PhD, Tampere University Hospital Heart Center

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Estimate): May 7, 2012
• Last Update Submitted That Met QC Criteria: May 4, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; Hypertonic saline; Extracellular fluid
• Other Study ID Numbers: R09246M; 2010-019352-42 (EudraCT Number)