Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
Recruitment status was Recruiting
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 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|
- The number of post-transplants all complications up to 30 days (Clavien grading). [ Time Frame: 30 days post-operative ] [ Designated as safety issue: Yes ]
- 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 ]
|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)|
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.
|Hospital Royal Victoria||Recruiting|
|Montreal, Quebec, Canada, H3A1A1|
|Contact: Jeanne M Bouteaud 514.934.1934 ext 36237 email@example.com|
|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|