Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery

McGill University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cardiac Surgery

Treatments: Other: Pentaspan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00337805

BMA-04-016

Details and patient eligibility

About

This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.

Enrollment: 240 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• status post cardiac surgery
• pulmonary artery occlusion catheter in place
• informed consent
• morning case (must be out of OR by 2:00 PM

Exclusion criteria

• excessive bleeding (> 200 cc/hr)
• intraaortic balloon pump
• refusal by treating team
• emergency cases
• patients with known adverse reactions to starch solutions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

1 colloid

Active Comparator group

Description:

Boluses of fluids are a pentastarch (up to 1000 ml)

Treatment:

Other: Pentaspan

2. Crytalloid

Active Comparator group

Description:

Boluses are given as normal saline

Treatment:

Other: Pentaspan