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Starch or Saline After Cardiac Surgery

NCT00964015 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-08-15

No results posted yet for this study

Summary

When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:

* to compensate for no oral intake
* to support blood pressure and organ function during and after surgery
* to replace lost fluid or blood volume

There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.

There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.

The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.

Conditions

  • Coronary Artery Bypass Surgery

Interventions

DRUG

6% Hydroxyethyl Starch 130/0.4

DRUG

0.9% Normal Saline

Sponsors & Collaborators

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Dave Nagpal, MD · LHSC / UWO

  • Ray Guo, MD · LHSC / UWO

  • Chris Harle, MD · LHSC / UWO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-06-30
Completion
2012-06-30

Countries

  • Canada

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 NCT00964015 on ClinicalTrials.gov