Starch or Saline After Cardiac Surgery (SSACS)

London Health Sciences Centre

Status: Terminated

Conditions: Coronary Artery Bypass Surgery

Treatments: Drug: 0.9% Normal Saline; Drug: 6% Hydroxyethyl Starch 130/0.4

Study type: Interventional

Funder types: Other

Identifiers

NCT00964015

LHSC

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups

Starch group

Active Comparator group

Description:

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

Treatment:

Drug: 6% Hydroxyethyl Starch 130/0.4

Saline group

Active Comparator group

Description:

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

Treatment:

Drug: 0.9% Normal Saline