IV Insulin Protocol in Diabetes and Renal Transplantation

Not Applicable

Completed

Interventions: Drug: NPH Insulin or glargine insulin and aspartame insulin
Drug: insulin

Brief 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.

Detailed Description: Research Design: A randomized control trial comparing intensive intravenous insulin (IVI) for use in the hospital followed by intensive subcutaneous (sc) insulin use for in-patient and out-patient glycemic control will be conducted.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Control	NPH Insulin or glargine insulin and aspartame insulin	The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
Intensive	insulin	The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.

Primary Outcome Measures

Name	Time	Method
Delayed Graft Function	10 days	Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.
Acute/Active Rejection	30 months	Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.

Secondary Outcome Measures