N/A
N=104
IV Insulin Protocol in Diabetes and Renal Transplantation
Kidney Transplantation · Diabetes · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00609986 ↗Enrolled (actual)
104
Serious AEs
1.1%
Results posted
Aug 2013
Primary outcome: Primary: Delayed Graft Function — 8; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- insulin (Drug); NPH Insulin or glargine insulin and aspartame insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delayed Graft Function |
8; 12 | — |
| PRIMARY Acute/Active Rejection |
9; 2 | — |
| SECONDARY Severe Hypoglycemia |
7; 2 | — |
| SECONDARY Severe Hyperglycemia |
5; 12 | — |
Summary
Purpose: The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery. After release from the hospital, the patient will control blood sugar with subcutaneous insulin injections or pills. With this approach, outcomes should improve for diabetic transplant patients such as longer life of the new kidney, fewer hospital readmissions, decreased associated infections, and other advantages.
Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical and biochemical outcomes and improved long-term graft survival.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and greater,
- Diabetes diagnosis (Type 1 and Type 2, awaiting a living or cadaveric renal transplant, renal transplant candidates admitted to MUSC medical center for a donor kidney, FBG >100 mg/dL per admission screening labs, random BG >120mg/dL per admission screening labs, and
- Willing and able to provide informed consent
Exclusion Criteria
- History of an active GI bleed in the previous 3 mos,
- Scheduled to receive a simultaneous pancreas transplant,
- History of a functioning pancreatic transplant,
- Patient currently managed on an insulin pump,
- Unable or unwilling to provide informed consent, and
- Unable to commit to the study protocol including the outpatient follow-up phase of care
Data sourced from ClinicalTrials.gov (NCT00609986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.