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Intensive Insulin Therapy in Deceased Donors

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ClinicalTrials.gov Identifier: NCT01140035
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : September 20, 2011
Sponsor:
Collaborator:
California Transplant Donor Network
Information provided by (Responsible Party):
Claus Niemann, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 10, 2009
First Posted Date  ICMJE June 9, 2010
Last Update Posted Date September 20, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
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) ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2010)
Graft function in kidney transplant recipient [ Time Frame: Transplant surgery to 3 months post transplant ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensive Insulin Therapy in Deceased Donors
Official Title  ICMJE Intensive Insulin Therapy in Deceased Donors - to Improve Renal Allograft Function and Transplanted Allograft Outcomes
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplant
Intervention  ICMJE Other: Administration of continuous insulin infusion for glycemic control in brain dead donors
As per protocol
Other Name: hyperglycemia
Study Arms  ICMJE 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

Intervention: Other: Administration of continuous insulin infusion for glycemic control in brain dead donors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 7, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Deceased Organ Donors

Exclusion Criteria:

  • Age less than 18 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01140035
Other Study ID Numbers  ICMJE R380T10586
HRSA R380T10586
HRSA ( Other Grant/Funding Number: HRSA R380T10586 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claus Niemann, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE California Transplant Donor Network
Investigators  ICMJE
Principal Investigator: Claus U Niemann, MD UC San Francisco
PRS Account University of California, San Francisco
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP