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

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 colloid

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

Group Type ACTIVE_COMPARATOR

Pentaspan

Intervention Type OTHER

When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

2. Crytalloid

Boluses are given as normal saline

Group Type ACTIVE_COMPARATOR

Pentaspan

Intervention Type OTHER

When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

Interventions

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Pentaspan

When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No