Postoperative Complications
Conditions
Keywords
Pancreas Transplantation, Kidney Transplantation, Organ Transplantation, Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients
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%.
Interventions
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).
Sponsors
Astellas Pharma Canada, Inc.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of post-transplants all complications up to 30 days (Clavien grading). | 30 days post-operative |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
Canada
Outcome results
None listed