Coronary Artery Bypass Surgery
Conditions
Keywords
colloid fluid, crystalloid fluid, surgery, coronary artery bypass grafting, renal function, Patients undergoing coronary artery bypass surgery
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.
Interventions
DRUG0.9% Normal Saline
Sponsors
London Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Incidence of atrial fibrillation (necessitating a change in medical management) | In hospital (up to 30 days) |
| Operative mortality | 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 |
| Volume of fluid infused | In hospital (up to 7 days) |
| Total hospital length of stay (when ready to leave tertiary hospital setting) | In hospital |
| Duration of oxygen supplementation | In hospital (up to 30 days) |
| Duration of ventilation support requirements | In hospital (up to 30 days) |
Countries
Canada
Outcome results
None listed