Starch or Saline After Cardiac Surgery
- Conditions
- Coronary Artery Bypass Surgery
- Interventions
- Drug: 0.9% Normal SalineDrug: 6% Hydroxyethyl Starch 130/0.4
- Registration Number
- NCT00964015
- Lead Sponsor
- London Health Sciences Centre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 69
- patients undergoing elective primary isolated on-pump coronary artery bypass grafting
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline group 0.9% Normal Saline Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements Starch group 6% Hydroxyethyl Starch 130/0.4 Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Total chest tube drainage (until removed) In hospital (up to 30 days) Transfusion of blood products In hospital (up to 30 days) Volume of fluid infused In hospital (up to 7 days) Duration of ventilation support requirements In hospital (up to 30 days) ICU length of stay In hospital (up to 30 days) Incidence of atrial fibrillation (necessitating a change in medical management) In hospital (up to 30 days) Creatinine, Urea, Cr Clearance as estimated by the MDRD formula In hospital at defined timepoints, and at 2 months post hospital discharge Total hospital length of stay (when ready to leave tertiary hospital setting) In hospital Operative mortality In hospital (up to 30 days) Duration of oxygen supplementation In hospital (up to 30 days)
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada