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

March 25, 2011 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre
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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • Recruiting
        • Hospital Royal Victoria
        • Contact:
        • Principal Investigator:
          • Steven Paraskevas, MD, PhD
        • Principal Investigator:
          • Mazen Hassanain, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of post-transplants all complications up to 30 days (Clavien grading).
Time Frame: 30 days post-operative
30 days post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Astellas Pharma Canada, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 23, 2009

First Posted (ESTIMATE)

October 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2011

Last Update Submitted That Met QC Criteria

March 25, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR-09-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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