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

NCT ID: NCT01001273

Last Updated: 2011-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-06-30

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%.

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Group

Hyperinsulinemic Normoglycemic Clamp will be started at the time of surgery (before incision) and will be continue for 3 days.

Group Type: EXPERIMENTAL

Hyperinsulinemic Normoglycemic Clamp

Intervention Type: OTHER

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).

Control Group

Patients in the control group will receive standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

MUHC

Locations

Hospital Royal Victoria

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Jeanne M Bouteaud

Role: primary

jeanne.bouteaud@muhc.mcgill.ca

514.934.1934 ext. 36237

Other Identifiers

SDR-09-061

Identifier Type: -

Identifier Source: org_study_id