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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00182377
Enrollment
Unknown
Registered
2005-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2007-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass

Keywords

patients undergoing cardiac surgery requiring cardiopulmonary bypass

Brief 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?

Interventions

DRUGPentastarch (displace either 500 ml or 1000 ml of pump prime with pentastarch)

Sponsors

Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
transfusion requirements—
fluid balance—

Secondary

MeasureTime frame
postoperative bleeding—
mediastinal drainage—
coagulation parameters—
respiratory status—

Countries

Canada

Contacts

Primary ContactIrene Cybulsky, MD
cybulsky@hhsc.ca905-777-8248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026