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

McGill University

Status: Unknown

Conditions: Postoperative Complications

Treatments: Other: Hyperinsulinemic Normoglycemic Clamp

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01001273

SDR-09-061

Details and patient eligibility

About

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%.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Study Group

Experimental group

Description:

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

Treatment:

Other: Hyperinsulinemic Normoglycemic Clamp

Control Group

No Intervention group

Description:

Patients in the control group will receive standard care.