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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01348659
Enrollment
48
Registered
2011-05-05
Start date
2011-05-31
Completion date
2012-05-31
Last updated
2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Volume Disorder

Keywords

Hypertonic saline, Extracellular fluid, cardiopulmonary bypass

Brief summary

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

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

DRUG7.2% 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.

DRUGNaCl 0.9%

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

Sponsors

Finnish Cultural Foundation
CollaboratorOTHER
Kati Järvelä
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in extracellular water from baseline to the first postoperative morning.24hPerioperative fluid balance will be assessed by measuring changes in body weight and extracellular water from baseline to the first postoperative morning.

Secondary

MeasureTime frameDescription
Need of fluids during the day of surgery.24hNeed of fluids and diuretic medication during the day of surgery until the first postoperative morning will be recorded.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026