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

This study has been completed.
Sponsor:
Collaborator:
Finnish Cultural Foundation
Information provided by (Responsible Party):
Kati Järvelä, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT01348659
First received: May 2, 2011
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Fluid Volume Disorder
Drug: 7.2% NaCl/hydroxyethylstarch
Drug: NaCl 0.9%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Hypertonic Saline-hydroxyethyl Starch Solution on Extracellular Water in Cardiac Surgery Patients

Resource links provided by NLM:


Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:
  • Change in extracellular water from baseline to the first postoperative morning. [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Perioperative fluid balance will be assessed by measuring changes in body weight and extracellular water from baseline to the first postoperative morning.


Secondary Outcome Measures:
  • Need of fluids during the day of surgery. [ Time Frame: 24h ] [ Designated as safety issue: No ]
    Need of fluids and diuretic medication during the day of surgery until the first postoperative morning will be recorded.


Enrollment: 48
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348659

Locations
Finland
Tampere University Hospital Heart Center
Tampere, Finland, 33521
Sponsors and Collaborators
Kati Järvelä
Finnish Cultural Foundation
Investigators
Principal Investigator: Kati Järvelä, MD, PhD Tampere University Hospital Heart Center
  More Information

No publications provided

Responsible Party: Kati Järvelä, MD, PhD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01348659     History of Changes
Other Study ID Numbers: R09246M, 2010-019352-42
Study First Received: May 2, 2011
Last Updated: May 4, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Tampere University Hospital:
Hypertonic saline
Extracellular fluid
cardiopulmonary bypass

Additional relevant MeSH terms:
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014