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

NCT01348659 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-05-07

No results posted yet for this study

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.

Conditions

  • Fluid Volume Disorder

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.

Sponsors & Collaborators

  • Finnish Cultural Foundation

    collaborator OTHER
  • Kati Järvelä

    lead OTHER

Principal Investigators

  • Kati Järvelä, MD, PhD · Tampere University Hospital Heart Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348659 on ClinicalTrials.gov