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

Overview

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.

Full Title of Study: “Effects of Hypertonic Saline-hydroxyethyl Starch Solution on Extracellular Water in Cardiac Surgery Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2012

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 7.2% NaCl/hydroxyethyl starch
    • 250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) (Hyperhaes®, Fresenius Kabi)
  • Active Comparator: 0.9% NaCl
    • 250 ml of NaCl 0.9% (Natriumklorid Braun 9 mg/ml)

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kati Järvelä
  • Collaborator
    • Finnish Cultural Foundation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Kati Järvelä, MD, PhD – Tampere University Hospital
  • Overall Official(s)
    • Kati Järvelä, MD, PhD, Principal Investigator, Tampere University Hospital Heart Center

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