NCT00182377

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?

Trial Health

55
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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2004

First QC Date

September 13, 2005

Last Update Submit

September 19, 2007

Conditions

Cardiac SurgeryCardiopulmonary Bypass

Keywords

patients undergoing cardiac surgery requiring cardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

  • transfusion requirements

  • fluid balance

Secondary Outcomes (4)

  • postoperative bleeding

  • mediastinal drainage

  • coagulation parameters

  • respiratory status

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences - General Division

Hamilton, Ontario, lL8L 2X2, Canada

RECRUITING

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Irene Cybulsky, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cybulsky, MD

CONTACT

905-777-8248cybulsky@hhsc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Last Updated

September 20, 2007

Record last verified: 2004-09

Locations

CA(1)