Double Blind Randomized Trial of Saline vs Pentaspan for... | NCT00337805

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

NCT00337805

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Status

Completed

Last Update Posted

Sep 18, 2009Estimated

Enrollment

240Actual

Phase

Phase 2Phase 3

Conditions

Cardiac Surgery

Interventions

Pentaspan

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Dec 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jun 14, 2006

First Submission Date that Met QC Criteria

Jun 14, 2006

First Posted Date

Jun 16, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER

Collaborators

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 colloid	Active Comparator	Boluses of fluids are a pentastarch (up to 1000 ml)	Other: Pentaspan
2. Crytalloid	Active Comparator	Boluses are given as normal saline	Other: Pentaspan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pentaspan	Other	When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment	1 colloid 2. Crytalloid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Use of catecholamines at 8:00 the morning after surgery		first post operative day

Secondary Outcomes

Measure	Description	Time Frame
Total use of catecholamines		Time in ICU
Time in the ICU		Time in ICU
Post-operative complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sheldon magder, md	McGill University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Victoria Hospital		Montreal	Quebec	H3A 1A1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23159133	Derived	Potter BJ, Deverenne B, Doucette S, Fergusson D, Magder S; Canadian Critical Care Trials Group. Cardiac output responses in a flow-driven protocol of resuscitation following cardiac surgery. J Crit Care. 2013 Jun;28(3):265-9. doi: 10.1016/j.jcrc.2012.09.008. Epub 2012 Nov 14.

ID	Term
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans