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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01001273
• Other study ID #: SDR-09-061
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2009
• Last updated: March 25, 2011
• Start date: April 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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).

Locations

Country	Name	City	State
Canada	Hospital Royal Victoria	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of post-transplants all complications up to 30 days (Clavien grading).		30 days post-operative	Yes
Secondary	The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)		30 days post-op	Yes
Secondary	The length of hospital stay (days)		Length of hospital stay (day 1 until discharge)	Yes