Pentastarch Use in Cardiac Surgery

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00182377
• Other study ID #: 02-183
• Status: Recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 19, 2007

Study information

• Verified date: September 2004
• Source: McMaster University
• Contact: Irene Cybulsky, MD
• Phone: 905-777-8248
• Email: cybulsky[@]hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Cardiopulmonary Bypass

Intervention

Drug:
• Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - General Division	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transfusion requirements
Primary	fluid balance
Secondary	postoperative bleeding
Secondary	mediastinal drainage
Secondary	coagulation parameters
Secondary	respiratory status