Overview

This trial is active, not recruiting.

Condition coronary artery bypass surgery
Treatments 6% hydroxyethyl starch 130/0.4, 0.9% normal saline
Sponsor London Health Sciences Centre
Start date August 2009
Trial size 300 participants
Trial identifier NCT00964015, LHSC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
6% hydroxyethyl starch 130/0.4
(Active Comparator)
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
0.9% normal saline

Primary Outcomes

Measure
Incidence of acute kidney injury as defined by RIFLE criteria
time frame: Short term (in hospital, up to 30 days) and mid-term (2 months)
Maximum postoperative weight gain
time frame: Short-term (in hospital, up to 7 days)

Secondary Outcomes

Measure
Operative mortality
time frame: In hospital (up to 30 days)
Duration of ventilation support requirements
time frame: In hospital (up to 30 days)
Total chest tube drainage (until removed)
time frame: In hospital (up to 30 days)
ICU length of stay
time frame: In hospital (up to 30 days)
Transfusion of blood products
time frame: In hospital (up to 30 days)
Incidence of atrial fibrillation (necessitating a change in medical management)
time frame: In hospital (up to 30 days)
Duration of oxygen supplementation
time frame: In hospital (up to 30 days)
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
time frame: In hospital at defined timepoints, and at 2 months post hospital discharge
Volume of fluid infused
time frame: In hospital (up to 7 days)
Total hospital length of stay (when ready to leave tertiary hospital setting)
time frame: In hospital

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients undergoing elective primary isolated on-pump coronary artery bypass grafting Exclusion Criteria: - pregnant patients - patients with an active intra-cranial bleed - patients with a history of hypersensitivity to starch solutions - patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2) - patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15

Additional Information

Official title Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
Principal investigator Ray Guo, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by London Health Sciences Centre.