Starch or Saline After Cardiac Surgery (SSACS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Bypass Surgery
• Intervention / Treatment: Drug: 6% Hydroxyethyl Starch 130/0.4; Drug: 0.9% Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Starch group; Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.	Drug: 6% Hydroxyethyl Starch 130/0.4
Active Comparator: Saline group; Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements	Drug: 0.9% Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Operative mortality	In hospital (up to 30 days)
Duration of ventilation support requirements	In hospital (up to 30 days)
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)
Duration of oxygen supplementation	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

Collaborators and Investigators

• Sponsor: London Health Sciences Centre
• Investigators: Study Director: Dave Nagpal, MD, LHSC / UWO; Principal Investigator: Ray Guo, MD, LHSC / UWO; Principal Investigator: Chris Harle, MD, LHSC / UWO

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 20, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 24, 2009

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: surgery; renal function; coronary artery bypass grafting; colloid fluid; crystalloid fluid; Patients undergoing coronary artery bypass surgery
• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: LHSC