Starch or Saline After Cardiac Surgery

Coronary Artery Bypass Surgery Clinical Trial

— SSACS  

Official title:

Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00964015
• Other study ID #: LHSC
• Status: Terminated
• Phase: N/A
• Start date: August 2009
• Est. completion date: June 2012

Study information

• Verified date: August 2019
• Source: London Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: June 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery

Intervention

Drug:
• 6% Hydroxyethyl Starch 130/0.4

• 0.9% Normal Saline

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute kidney injury as defined by RIFLE criteria		Short term (in hospital, up to 30 days) and mid-term (2 months)
Primary	Maximum postoperative weight gain		Short-term (in hospital, up to 7 days)
Secondary	Operative mortality		In hospital (up to 30 days)
Secondary	Duration of ventilation support requirements		In hospital (up to 30 days)
Secondary	Total chest tube drainage (until removed)		In hospital (up to 30 days)
Secondary	ICU length of stay		In hospital (up to 30 days)
Secondary	Transfusion of blood products		In hospital (up to 30 days)
Secondary	Incidence of atrial fibrillation (necessitating a change in medical management)		In hospital (up to 30 days)
Secondary	Duration of oxygen supplementation		In hospital (up to 30 days)
Secondary	Creatinine, Urea, Cr Clearance as estimated by the MDRD formula		In hospital at defined timepoints, and at 2 months post hospital discharge
Secondary	Volume of fluid infused		In hospital (up to 7 days)
Secondary	Total hospital length of stay (when ready to leave tertiary hospital setting)		In hospital