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

Fluid Volume Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348659
• Other study ID #: R09246M
• Secondary ID: 2010-019352-42
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2011
• Last updated: May 4, 2012
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fluid Volume Disorder

Intervention

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

Locations

Country	Name	City	State
Finland	Tampere University Hospital Heart Center	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Kati Järvelä	Finnish Cultural Foundation

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No