Starch or Saline After Cardiac Surgery (SSACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00964015
Recruitment Status : Unknown
Verified December 2011 by London Health Sciences Centre.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2009
Last Update Posted : January 4, 2012
Information provided by:
London Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Surgery Drug: 6% Hydroxyethyl Starch 130/0.4 Drug: 0.9% Normal Saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
Study Start Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Incidence of acute kidney injury as defined by RIFLE criteria [ Time Frame: Short term (in hospital, up to 30 days) and mid-term (2 months) ]
  2. Maximum postoperative weight gain [ Time Frame: Short-term (in hospital, up to 7 days) ]

Secondary Outcome Measures :
  1. Operative mortality [ Time Frame: In hospital (up to 30 days) ]
  2. Duration of ventilation support requirements [ Time Frame: In hospital (up to 30 days) ]
  3. Total chest tube drainage (until removed) [ Time Frame: In hospital (up to 30 days) ]
  4. ICU length of stay [ Time Frame: In hospital (up to 30 days) ]
  5. Transfusion of blood products [ Time Frame: In hospital (up to 30 days) ]
  6. Incidence of atrial fibrillation (necessitating a change in medical management) [ Time Frame: In hospital (up to 30 days) ]
  7. Duration of oxygen supplementation [ Time Frame: In hospital (up to 30 days) ]
  8. Creatinine, Urea, Cr Clearance as estimated by the MDRD formula [ Time Frame: In hospital at defined timepoints, and at 2 months post hospital discharge ]
  9. Volume of fluid infused [ Time Frame: In hospital (up to 7 days) ]
  10. Total hospital length of stay (when ready to leave tertiary hospital setting) [ Time Frame: In hospital ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00964015

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
London Health Sciences Centre
Study Director: Dave Nagpal, MD LHSC / UWO
Principal Investigator: Ray Guo, MD LHSC / UWO
Principal Investigator: Chris Harle, MD LHSC / UWO

Responsible Party: Dave Nagpal, London Health Sciences Centre Identifier: NCT00964015     History of Changes
Other Study ID Numbers: LHSC
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: December 2011

Keywords provided by London Health Sciences Centre:
colloid fluid
crystalloid fluid
coronary artery bypass grafting
renal function
Patients undergoing coronary artery bypass surgery

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes