Starch or Saline After Cardiac Surgery

NCT00964015 | Terminated DMC

• 1 other identifier: LHSC
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Keywords

colloid fluid; crystalloid fluid; surgery; coronary artery bypass grafting; renal function; Patients undergoing coronary artery bypass surgery

Outcome Measures

Primary Outcomes (2)

• Incidence of acute kidney injury as defined by RIFLE criteria

  Short term (in hospital, up to 30 days) and mid-term (2 months)

• Maximum postoperative weight gain

  Short-term (in hospital, up to 7 days)

Secondary Outcomes (10)

• Operative mortality

  In hospital (up to 30 days)

• Duration of ventilation support requirements

  In hospital (up to 30 days)

• Total chest tube drainage (until removed)

  In hospital (up to 30 days)

• ICU length of stay

  In hospital (up to 30 days)

• Transfusion of blood products

  In hospital (up to 30 days)

Study Arms (2)

Starch group

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.

Drug: 6% Hydroxyethyl Starch 130/0.4

Saline group

ACTIVE COMPARATOR

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

Drug: 0.9% Normal Saline

Interventions

6% Hydroxyethyl Starch 130/0.4 DRUG

Starch group

0.9% Normal Saline DRUG

Saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective primary isolated on-pump coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; Saline Solution

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dave Nagpal, MD

  LHSC / UWO

  STUDY DIRECTOR

• Ray Guo, MD

  LHSC / UWO

  PRINCIPAL INVESTIGATOR

• Chris Harle, MD

  LHSC / UWO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiac Surgery and Critical Care Medicine, Surgical Director of Heart Failure and Mechanical Circulatory Support Program

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 24, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2012
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

CA (1)