Starch or Saline After Cardiac Surgery - Full Text View

Purpose

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	Intervention
Coronary Artery Bypass Surgery	Drug: 6% Hydroxyethyl Starch 130/0.4 Drug: 0.9% Normal Saline

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Surgery

Drug Information available for: Hetastarch

U.S. FDA Resources

Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:

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) ] [ Designated as safety issue: Yes ]
Maximum postoperative weight gain [ Time Frame: Short-term (in hospital, up to 7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Operative mortality [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: Yes ]
Duration of ventilation support requirements [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: No ]
Total chest tube drainage (until removed) [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: No ]
ICU length of stay [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: No ]
Transfusion of blood products [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: Yes ]
Incidence of atrial fibrillation (necessitating a change in medical management) [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: No ]
Duration of oxygen supplementation [ Time Frame: In hospital (up to 30 days) ] [ Designated as safety issue: No ]
Creatinine, Urea, Cr Clearance as estimated by the MDRD formula [ Time Frame: In hospital at defined timepoints, and at 2 months post hospital discharge ] [ Designated as safety issue: No ]
Volume of fluid infused [ Time Frame: In hospital (up to 7 days) ] [ Designated as safety issue: No ]
Total hospital length of stay (when ready to leave tertiary hospital setting) [ Time Frame: In hospital ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2009

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964015

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Dave Nagpal, London Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00964015 History of Changes
Other Study ID Numbers:	LHSC
Study First Received:	August 20, 2009
Last Updated:	January 3, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by London Health Sciences Centre:

colloid fluid
crystalloid fluid
surgery

coronary artery bypass grafting
renal function
Patients undergoing coronary artery bypass surgery

Additional relevant MeSH terms:

Hetastarch
Plasma Substitutes
Blood Substitutes

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013

Starch or Saline After Cardiac Surgery (SSACS)