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

McGill University Health Centre/Research Institute of the McGill University Health Centre80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Postoperative Complications

Interventions

Hyperinsulinemic Normoglycemic ClampOTHER

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Royal Victoria

Montreal, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

The number of post-transplants all complications up to 30 days (Clavien grading).

Time frame: 30 days post-operative

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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