Post-Operative Use of Salt Poor Albumin Solution in Resus... | NCT00842803

Studies
Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant

NCT00842803

Sponsor

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

Status

Unknown status

Last Update Posted

Sep 18, 2009Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Liver Transplantation

Interventions

Albumin infusion (25% albumin)

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

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Feb 11, 2009

First Submission Date that Met QC Criteria

Feb 11, 2009

First Posted Date

Feb 12, 2009Estimated

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

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention	Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative
Albumin group	Experimental	Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative	Drug: Albumin infusion (25% albumin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albumin infusion (25% albumin)	Drug	Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative	Albumin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post Transplant Liver Function Test (PTLFT)		Post-operative Day1 through 7 and Day 15,30, 45

Secondary Outcomes

Measure	Description	Time Frame
Functional 6 minutes walking test		Post-operative
Calculated creatinine clearance		Post-operative day 1, 7, 15, 30, 45
Length of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Canadian Transplant status 1 or 2
Patients at the Royal Victoria Hospital, Montreal, Canada

Exclusion Criteria:

Emergency liver transplant (canadian transplant status 3 or 4)
patients who have received more than 300cc of albumin within 48 hours prior to transplant
patients who underwent previous solid organ transplant
multi-organs transplant recipients
patients who had previous adverse reaction to human albumin solution
patients who have religious restriction to receiving human blood products.
patients or surrogate unable to give consent to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mathieu Rousseau, MD	Contact	514.567.0292		mathieu.rousseau@mail.mcgill.ca
Mazen Hassanain, MD	Contact	514.934.1934	31600	mazen.hassanain@muhc.mcgill.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Victoria Hospital		Montreal	Quebec	H3A1A1	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D000418	Albumins

Ancestor Terms

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided