Clinical trial NCT00964015: Starch or Saline After Cardiac Surgery
Official title: Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Bypass Surgery
Keywords: colloid fluid
crystalloid fluid
surgery
coronary artery bypass grafting
renal function
Patients undergoing coronary artery bypass surgery
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of acute kidney injury as defined by RIFLE criteria
timeFrame: Short term (in hospital, up to 30 days) and mid-term (2 months)
measure: Maximum postoperative weight gain
timeFrame: Short-term (in hospital, up to 7 days)
Secondary outcomes:
measure: Operative mortality
timeFrame: In hospital (up to 30 days)
measure: Duration of ventilation support requirements
timeFrame: In hospital (up to 30 days)
measure: Total chest tube drainage (until removed)
timeFrame: In hospital (up to 30 days)
measure: ICU length of stay
timeFrame: In hospital (up to 30 days)
measure: Transfusion of blood products
timeFrame: In hospital (up to 30 days)
measure: Incidence of atrial fibrillation (necessitating a change in medical management)
timeFrame: In hospital (up to 30 days)
measure: Duration of oxygen supplementation
timeFrame: In hospital (up to 30 days)
measure: Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
timeFrame: In hospital at defined timepoints, and at 2 months post hospital discharge
measure: Volume of fluid infused
timeFrame: In hospital (up to 7 days)
measure: Total hospital length of stay (when ready to leave tertiary hospital setting)
timeFrame: In hospital
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: LHSC / UWO
name: Dave Nagpal, MD
role: STUDY_DIRECTOR
affiliation: LHSC / UWO
name: Ray Guo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LHSC / UWO
name: Chris Harle, MD
role: PRINCIPAL_INVESTIGATOR
References: