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NCT01140035 · ClinicalTrials.gov registry record · NA
Intensive Insulin Therapy in Deceased Donors
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01140035: Completed NA study, sponsored by University of California, San Francisco.
NCT01140035 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01140035, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study 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 i
Primary Outcome
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.
Interventions
- OTHER Administration of continuous insulin infusion for glycemic control in brain dead donors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-09 |
| Phase | NA |
What the finished NCT01140035 record still lists
NCT01140035 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Administration of continuous insulin infusion for glycemic control in brain dead donors is the first listed.
NCT01140035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01140035 about?
NCT01140035 is a clinical study titled "Intensive Insulin Therapy in Deceased Donors". 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 requir...
What is the current status of trial NCT01140035?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2009-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01140035?
The interventions under investigation include: Administration of continuous insulin infusion for glycemic control in brain dead donors (OTHER).
Who is sponsoring clinical trial NCT01140035?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01140035's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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