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NCT Number: NCT01348659

Effects of Hypertonic Saline-HES 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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital Heart Center

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

7.2% NaCl/hydroxyethylstarch

Drug

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

NaCl 0.9%

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kati Järvelä

Other

Collaborators

  • Finnish Cultural Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 5, 2011
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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