Clinical trial NCT01643382
Conditions: Diabetes End Stage Renal Disease
Keywords: diabetes kidney transplant end stage renal disease delayed draft function
Sponsor: University of California, San Francisco
Start date: 2012-08-01; Completion date: 2014-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Based on multiple prior studies, kidney transplant recipients with diabetes are at higher risk for poor initial graft function after transplant. Our study is designed to determine if tight blood sugar control around the time of kidney transplant will improve short term graft function.

Detailed description:
Population- Our study population will include all adult diabetic patients undergoing deceased donor renal transplantation or living donor transplantation in which a swap requires transportation and resulting cold storage time. This will ensure a reasonable incidence of our primary outcome (poor short term graft function) and eliminate the potential risk of treating non-diabetic patients with insulin infusions. Patients already enrolled in a drug trial designed to study the impact of the drug on graft function will be excluded.

Study Design- This will be a randomized control trial. Recipients will be randomized to either tight peri-operative glucose control or standard management.

Methods

Randomization Protocol- In order to ensure that patients are equally distributed between groups, we will use block randomization. Blocks of 4 patients will be created with the total number of experimental versus control assignments being equal across blocks. Patients will then be randomly assigned to a block.

Interventions- The study group will be treated with an insulin infusion to achieve tight glycemic control (100-140mg/dL). Each study patient will be started on an insulin infusion prior to their operation. This infusion will continue throughout the operation and for 24 hours after completion of the transplant. Glucose control will then be left to the discretion of the primary team.

The control group will be treated with bolus insulin based on a standard insulin sliding scale.

Outcomes

Aim 1-

Primary endpoint- Our primary endpoint will be poor initial graft function defined by the occurrence of DGF (defined by a decrease in serum creatinine of \<10%/day for 3 consecutive days after transplant) or slow graft function (serum creatinine \>3 mg/dL 5 days after transplant without dialysis)

Secondary endpoint- Secondary endpoints will include wound infection, length of hospital stay, 30 day mortality, hypoglycemic episodes(glucose \<70 mg/dL) and stroke.

Aim 2-

Primary endpoint- Our primary endpoints will be acute rejection at 90 days and graft survival/renal function at 3months, 6months and then yearly.

Statistical Analysis- Data will be described as means with standard deviations or percentages with ranges based on whether the data represent continuous or categorical variables. The t-test and chi-squared test will be used to test hypotheses.

Arms: arm 1: Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip. arm 2: Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.
Interventions: intervention 1: Insulin intervention 2: Insulin, Asp(B28)-
Intervention descriptions: intervention 1: Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL intervention 2: Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.

Protocol documents: