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

Not Applicable

• Conditions: Postoperative Complications

• Registration Number: NCT01001273
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-23
• Study First Posted: 2009-10-26
• Study Start: 2010-04
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28
• Primary Completion: 2012-04
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The number of post-transplants all complications up to 30 days (Clavien grading).	30 days post-operative

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Royal Victoria; 🇨🇦 Montreal, Quebec, Canada