Recruiting

Hyperinsulinemic Clamp

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT01001273

Conditions

Postoperative Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperinsulinemic Normoglycemic Clamp

Study Details

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%.

Conditions

Postoperative Complications

Study ID

NCT01001273

Start date

Apr, 2010

Status verified date

Mar, 2011

Completion date

Jun, 2012

Anticipated

Primary completion date

Apr, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Study Group

Hyperinsulinemic Normoglycemic Clamp will be started at the time of surgery (before incision) and will be continue for 3 days.

no intervention: Control Group

Patients in the control group will receive standard care.

Interventions

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).

Primary outcome measure

  • The number of post-transplants all complications up to 30 days (Clavien grading). [ Time Frame: 30 days post-operative ]

Central Contacts and Locations

Locations

Hospital Royal Victoria

Recruiting

Montreal, Quebec, Canada, H3A1A1

Contacts

Jeanne M Bouteaud

514.934.1934jeanne.bouteaud@muhc.mcgill.ca

Principal Investigator:

Steven Paraskevas, MD, PhD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 28, 2011

Last verified

Mar, 2011

Keywords

  • Pancreas Transplantation
  • Kidney Transplantation
  • Organ Transplantation
  • Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2011-03-28.