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

NCT01001273 | Unknown

• 1 other identifier: SDR-09-061
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  30 days post-operative

Secondary Outcomes (2)

• 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)

Study Arms (2)

Study Group

EXPERIMENTAL

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

Other: Hyperinsulinemic Normoglycemic Clamp

Control Group

NO INTERVENTION

Patients in the control group will receive standard care.

Interventions

Hyperinsulinemic Normoglycemic Clamp OTHER

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).

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Multi-organ transplant other than kidney transplant
• No central venous access available to deliver the D20W solution

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (1)

Hospital Royal Victoria

Montreal, Quebec, H3A1A1, Canada

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 26, 2009
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 28, 2011

Record last verified: 2011-03

Locations

CA (1)