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

Primary Purpose

Postoperative Complications

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Hyperinsulinemic Normoglycemic Clamp

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring Pancreas Transplantation, Kidney Transplantation, Organ Transplantation, Pancreas and Simultaneous Pancreas/Kidney Transplant Recipients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Royal VictoriaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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

Patients in the control group will receive standard care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)

The length of hospital stay (days)

Full Information

NCT ID

NCT01001273

First Posted

October 22, 2009

Last Updated

March 25, 2011

Sponsor

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

Collaborators

Astellas Pharma Canada, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01001273

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

Astellas Pharma Canada, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Patients in the control group will receive standard care.

Intervention Type

Other

Intervention Name(s)

Hyperinsulinemic Normoglycemic Clamp

Intervention Description

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 Information:

Title

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

Time Frame

30 days post-operative

Secondary Outcome Measure Information:

Title

The number of 30 days post-transplant serious medical complication (Clavien grade 3, 4)

Time Frame

30 days post-op

Title

The length of hospital stay (days)

Time Frame

Length of hospital stay (day 1 until discharge)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hospital Royal Victoria

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A1A1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeanne M Bouteaud

Phone

514.934.1934

Ext

36237

jeanne.bouteaud@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Steven Paraskevas, MD, PhD

First Name & Middle Initial & Last Name & Degree

Mazen Hassanain, MD

First Name & Middle Initial & Last Name & Degree

Peter Metrakos, MD

First Name & Middle Initial & Last Name & Degree

Prosanto K Chaudhury, MD, Msc

First Name & Middle Initial & Last Name & Degree

Jean Tchervenkov, MD

First Name & Middle Initial & Last Name & Degree

Marcelo Cantarovitch, MD

First Name & Middle Initial & Last Name & Degree

George Carvalho, MD

First Name & Middle Initial & Last Name & Degree

Ralph Lattermann, MD

First Name & Middle Initial & Last Name & Degree

Thomas Schricker, MD

12. IPD Sharing Statement

Learn more about this trial

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

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