Intensive Insulin Therapy in Deceased Donors

This study has been completed.
Sponsor:
Collaborator:
California Transplant Donor Network
Information provided by (Responsible Party):
Claus Niemann, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01140035
First received: September 10, 2009
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

Every year in the US, there is a shortage of many thousands of kidneys needed for transplant. Furthermore, kidneys that are available and are transplanted often exhibit delayed or slow graft function (DGF and SGF, respectively), which lowers quality of life for patients and their families and requires significant additional medical care. These needs result in significant but preventable human suffering and health care spending. To address these needs, the investigators' project will test the use of intensive insulin therapy (IIT) in donors after neurological determination of death (DNDDs) as an intervention that will decrease acute kidney injury and improve renal function at the time of organ recovery. This should translate into a decreased incidence of DGF and SFG in recipients receiving organs from the IIT group. The investigators also expect to find a trend toward an increase in the number of organs available for transplant due to better organ protection in the DNDD. Taken together, these data can provide the requisite justification for a larger study that can be powered to evaluate the effect of IIT on increasing the number of kidneys available for transplantation.

There is evidence that brain death often leads to hyperglycemia that may negatively impacts the organs of DNDDs. These observations led us to conduct a retrospective study, in which the investigators found that hyperglycemia in DNDDs is indeed associated with decreased terminal renal function. Because it has been reported that intensive insulin therapy (ITT) is renoprotective in the ICU more than conventional insulin therapy (CIT), the investigators propose to evaluate the use of IIT on DNDDs to: (1) improve organ function, (2) reduce DGF in recipients, and (3) possibly increase the number of kidney available for transplant.

Methods: This is a prospective observational study to document the impact of IIT on acute kidney injury in DNDDS and on allograft function in recipients. DNDDs will be divided into two groups: CIT and IIT. In the first study, the investigators will evaluate the effect of ITT on biochemical parameters in blood samples that predict kidney health and function in DNDDs. All methods used in this proposal are well documented in the literature and established in the applicant's laboratory. In the investigators' second study, they will compare the effects of ITT in DNDDs on graft function in allograft recipients in terms of number of patients showing either DGF or SGF. Additionally, there is currently no established set of advanced biochemical criteria in DNDDs for predicting kidney function in recipients. The investigators will correlate the evaluated biochemical markers of kidney function and health in order to possibly develop more refined methods of predicting transplant success. Such a set of criteria would be useful for designing studies to systematically test additional interventions in DNDDs to further improve organ function before recovery and further increase the number of available organs.

Taken together, the results of this study may lead to new therapies that significantly improve patient outcomes while significantly reducing disease associated costs. These results can also set the stage for a follow on study for increasing the number of kidneys available for transplant.


Condition Intervention
Kidney Transplant
Other: Administration of continuous insulin infusion for glycemic control in brain dead donors

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Intensive Insulin Therapy in Deceased Donors - to Improve Renal Allograft Function and Transplanted Allograft Outcomes

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Renal Function in donor at the time of Aortic cross clamping [ Time Frame: Between declaration of brain death and organ recovery (in average this period is 48 hrs) ] [ Designated as safety issue: No ]
    once organ donors are declared brain death and donor is consented for research, donor is randomized to control or experimental arm of study. The donation process between declaration of brain death and organ recovery is approximately 48 in our region.


Secondary Outcome Measures:
  • Graft function in kidney transplant recipient [ Time Frame: Transplant surgery to 3 months post transplant ] [ Designated as safety issue: No ]
    Grafts of donors enrolled in the study will be followed in the recipient for 3 months. This time is sufficient to capture initial delayed graft function and short term renal function.


Estimated Enrollment: 200
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive insulin therapy

Intensive insulin therapy with goal of glucose < 150 mg/dl

Control group with standard insulin therapy with goal of glucose 180 mg/dl

Other: Administration of continuous insulin infusion for glycemic control in brain dead donors
As per protocol
Other Name: hyperglycemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Deceased Organ Donors

Exclusion Criteria:

  • Age less than 18 years
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01140035

Locations
United States, California
U C San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
California Transplant Donor Network
Investigators
Principal Investigator: Claus U Niemann, MD UC San Francisco
  More Information

No publications provided

Responsible Party: Claus Niemann, Associate Professor of Anesthesia & Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01140035     History of Changes
Other Study ID Numbers: R380T10586, HRSA R380T10586, HRSA
Study First Received: September 10, 2009
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Insulin
Deceased donors
Renal Allograft Function
Transplanted Allograft Outcomes

Additional relevant MeSH terms:
Death
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014