NCT00182377

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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?

Conditions

• Cardiac Surgery
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
DRUG	Pentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

Timeline

• First posted: 2005-09-16
• Last updated: 2007-09-20

Locations

1 site across 1 country: Canada