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Pentastarch Use in Cardiac Surgery

NCT ID: NCT00182377

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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?

Detailed Description

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Conditions

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Cardiac Surgery Cardiopulmonary Bypass

Keywords

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patients undergoing cardiac surgery requiring cardiopulmonary bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Principal Investigators

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Irene Cybulsky, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton Health Sciences - General Division

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Irene Cybulsky, MD

Role: CONTACT

Phone: 905-777-8248

Email: [email protected]

Facility Contacts

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Mary-Helen Blackall

Role: primary

Other Identifiers

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02-183

Identifier Type: -

Identifier Source: org_study_id