Clinical trial NCT01140035: Intensive Insulin Therapy in Deceased Donors
Official title: Intensive Insulin Therapy in Deceased Donors - to Improve Renal Allograft Function and Transplanted Allograft Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Keywords: Insulin
Deceased donors
Renal Allograft Function
Transplanted Allograft Outcomes
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: California Transplant Donor Network
First posted: 2010-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Deceased Organ Donors

Exclusion Criteria:

* Age less than 18 years

Primary outcomes:
measure: Renal Function in donor at the time of Aortic cross clamping
timeFrame: Between declaration of brain death and organ recovery (in average this period is 48 hrs)
Secondary outcomes:
measure: Graft function in kidney transplant recipient
timeFrame: Transplant surgery to 3 months post transplant
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: U C San Francisco
state: California
Study officials:
affiliation: UC San Francisco
name: Claus U Niemann, MD
role: PRINCIPAL_INVESTIGATOR
References: