Pentastarch Use in Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182377
First received: September 13, 2005
Last updated: September 19, 2007
Last verified: September 2004
  Purpose

Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?


Condition Intervention
Cardiac Surgery
Cardiopulmonary Bypass
Drug: Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Blinded Clinical Trial to Evaluate the Efficacy and Safety of Pentastarch Use in Patients Undergoing Coronary Artery Bypass Surgery or Valve Replacement Surgery Using Cardiopulmonary Bypass Circuits

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • transfusion requirements
  • fluid balance

Secondary Outcome Measures:
  • postoperative bleeding
  • mediastinal drainage
  • coagulation parameters
  • respiratory status

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing either coronary artery bypass surgery or valve surgery requiring the use of cardiopulmonary bypass circuit

Exclusion Criteria:

  • Emergency surgery
  • Regurgitant valve pathology
  • Redo surgery
  • Significant left ventricular (LV) dysfunction
  • Significant renal insufficiency
  • Anticipation of associated procedure - eg carotid endarterectomy
  • Ongoing sepsis or endocarditis
  • Received aspirin (ASA) or Plavix within 96 hours of surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182377

Contacts
Contact: Irene Cybulsky, MD 905-777-8248 cybulsky@hhsc.ca

Locations
Canada, Ontario
Hamilton Health Sciences - General Division Recruiting
Hamilton, Ontario, Canada, lL8L 2X2
Contact: Mary-Helen Blackall    905 -527-4322 ext 44228    blackall @hhsc.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Irene Cybulsky, MD McMaster University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00182377     History of Changes
Other Study ID Numbers: 02-183
Study First Received: September 13, 2005
Last Updated: September 19, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
patients undergoing cardiac surgery requiring cardiopulmonary bypass

Additional relevant MeSH terms:
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014