Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01001273|
Recruitment Status : Unknown
Verified March 2011 by McGill University Health Center.
Recruitment status was: Recruiting
First Posted : October 26, 2009
Last Update Posted : March 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications||Other: Hyperinsulinemic Normoglycemic Clamp||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyperinsulinemic Normoglycemic Clamp for Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2012|
|Estimated Study Completion Date :||June 2012|
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.
- The number of post-transplants all complications up to 30 days (Clavien grading). [ Time Frame: 30 days post-operative ]
- The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4) [ Time Frame: 30 days post-op ]
- The length of hospital stay (days) [ Time Frame: Length of hospital stay (day 1 until discharge) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001273
|Hospital Royal Victoria||Recruiting|
|Montreal, Quebec, Canada, H3A1A1|
|Contact: Jeanne M Bouteaud 514.934.1934 ext 36237 firstname.lastname@example.org|
|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|