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

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ClinicalTrials.gov Identifier: NCT00842803
Recruitment Status : Unknown
Verified September 2009 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : February 12, 2009
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
McGill University Health Center

Tracking Information
First Submitted Date  ICMJE February 11, 2009
First Posted Date  ICMJE February 12, 2009
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
Post Transplant Liver Function Test (PTLFT) [ Time Frame: Post-operative Day1 through 7 and Day 15,30, 45 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00842803 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
  • Functional 6 minutes walking test [ Time Frame: Post-operative ]
  • Calculated creatinine clearance [ Time Frame: Post-operative day 1, 7, 15, 30, 45 ]
  • Length of hospital stay [ Time Frame: post-operative ]
  • ICU length of stay [ Time Frame: post-operative ]
  • duration of mechanical ventilation [ Time Frame: post-operative ]
  • duration of renal replacement therapy [ Time Frame: postoperative ]
  • ICU readmission rate [ Time Frame: post-operative ]
  • reintubation rate [ Time Frame: post-operative ]
  • Post-operative infection rate [ Time Frame: Post-operative ]
  • Need to re-operation unrelated to technical complication [ Time Frame: post-operative ]
  • Functional hand grip Jamar Dynamometer hand grip test [ Time Frame: Post-op day 7, 15, 30 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant
Official Title  ICMJE Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Liver Transplantation
Intervention  ICMJE Drug: Albumin infusion (25% albumin)
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
Study Arms  ICMJE
  • No Intervention: Control Group
    Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative
  • Experimental: Albumin group
    Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
    Intervention: Drug: Albumin infusion (25% albumin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 11, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842803
Other Study ID Numbers  ICMJE SDR-08-030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Peter Metrakos, MUHC
Study Sponsor  ICMJE McGill University Health Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account McGill University Health Center
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP