Starch or Saline After Cardiac Surgery

NCT ID: NCT00964015

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Starch group

Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.

Group Type: ACTIVE_COMPARATOR

6% Hydroxyethyl Starch 130/0.4

Intervention Type: DRUG

Saline group

Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements

Group Type: ACTIVE_COMPARATOR

0.9% Normal Saline

Intervention Type: DRUG

Interventions

6% Hydroxyethyl Starch 130/0.4

Intervention Type: DRUG

0.9% Normal Saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dave Nagpal

Associate Professor of Cardiac Surgery and Critical Care Medicine, Surgical Director of Heart Failure and Mechanical Circulatory Support Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dave Nagpal, MD

Role: STUDY_DIRECTOR

LHSC / UWO

Ray Guo, MD

Role: PRINCIPAL_INVESTIGATOR

LHSC / UWO

Chris Harle, MD

Role: PRINCIPAL_INVESTIGATOR

LHSC / UWO

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

LHSC

Identifier Type: -

Identifier Source: org_study_id