Pentastarch Use in Cardiac Surgery

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

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?

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass
• Intervention / Treatment: Drug: Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, lL8L 2X2
      • Recruiting
      • Hamilton Health Sciences - General Division
      • Contact: Mary-Helen Blackall; Phone Number: 44228 905 -527-4322; Email: blackall @hhsc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
transfusion requirements
fluid balance

Secondary Outcome Measures

Outcome Measure
postoperative bleeding
mediastinal drainage
coagulation parameters
respiratory status

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Irene Cybulsky, MD, McMaster University

Study record dates

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): September 20, 2007
• Last Update Submitted That Met QC Criteria: September 19, 2007
• Last Verified: September 1, 2004

More Information

Terms related to this study

• Keywords: patients undergoing cardiac surgery requiring cardiopulmonary bypass
• Additional Relevant MeSH Terms: Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: 02-183