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Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT01001273
Recruitment Status : Unknown
Verified March 2011 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : October 26, 2009
Last Update Posted : March 28, 2011
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by:
McGill University Health Center

Brief Summary:
This study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. The investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.

Condition or disease Intervention/treatment
Postoperative Complications Other: Hyperinsulinemic Normoglycemic Clamp

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
Study Start Date : April 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Study Group
Hyperinsulinemic Normoglycemic Clamp will be started at the time of surgery (before incision) and will be continue for 3 days.
Other: Hyperinsulinemic Normoglycemic Clamp
The patient receives insulin intravenous infusion at 2ml units/kg/min. Dextrose 20% (D20W ®) will be titrated to maintain blood glucose between 4 - 6 mmol/L (72 - 108 mg/dl).
No Intervention: Control Group
Patients in the control group will receive standard care.



Primary Outcome Measures :
  1. The number of post-transplants all complications up to 30 days (Clavien grading). [ Time Frame: 30 days post-operative ]

Secondary Outcome Measures :
  1. The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4) [ Time Frame: 30 days post-op ]
  2. The length of hospital stay (days) [ Time Frame: Length of hospital stay (day 1 until discharge) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patient over 18 years of age
  • Patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant
  • Able to give written informed consent prior to any study specific procedure

Exclusion Criteria:

  • Multi-organ transplant other than kidney transplant
  • No central venous access available to deliver the D20W solution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001273


Locations
Canada, Quebec
Hospital Royal Victoria Recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Jeanne M Bouteaud    514.934.1934 ext 36237    jeanne.bouteaud@muhc.mcgill.ca   
Principal Investigator: Steven Paraskevas, MD, PhD         
Principal Investigator: Mazen Hassanain, MD         
Sub-Investigator: Peter Metrakos, MD         
Sub-Investigator: Prosanto K Chaudhury, MD, Msc         
Sub-Investigator: Jean Tchervenkov, MD         
Sub-Investigator: Marcelo Cantarovitch, MD         
Sub-Investigator: George Carvalho, MD         
Sub-Investigator: Ralph Lattermann, MD         
Sub-Investigator: Thomas Schricker, MD         
Sponsors and Collaborators
McGill University Health Center
Astellas Pharma Canada, Inc.

Responsible Party: Dr Steven Paraskevas & Dr Mazen Hassanain, MUHC
ClinicalTrials.gov Identifier: NCT01001273     History of Changes
Other Study ID Numbers: SDR-09-061
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: March 2011

Keywords provided by McGill University Health Center:
Pancreas Transplantation
Kidney Transplantation
Organ Transplantation
Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Pancrelipase
Pancreatin
Gastrointestinal Agents