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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01001273
First received: October 22, 2009
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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 Intervention
Postoperative Complications
Other: Hyperinsulinemic Normoglycemic Clamp

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • The number of post-transplants all complications up to 30 days (Clavien grading). [ Time Frame: 30 days post-operative ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Dr Steven Paraskevas & Dr Mazen Hassanain, MUHC
ClinicalTrials.gov Identifier: NCT01001273     History of Changes
Other Study ID Numbers: SDR-09-061
Study First Received: October 22, 2009
Last Updated: March 25, 2011
Health Authority: Canada: Ethics Review Committee

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
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014