IV Insulin Protocol in Diabetes and Renal Transplantation
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|ClinicalTrials.gov Identifier: NCT00609986|
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : August 7, 2013
Last Update Posted : September 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation Diabetes Hyperglycemia||Drug: insulin Drug: NPH Insulin or glargine insulin and aspartame insulin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
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.
The intravenous regular insulin infusion will be delivered continuously during the transplant surgery and after surgery for a total of three days. While receiving the insulin infusion, the dose will be calculated to keep the blood sugar levels between 70-110 mg/dL.
After the regular insulin infusion is discontinued, the blood sugar levels will be measured by a finger stick blood glucose up to 5-6 times per day and the blood sugar levels will be corrected by a subcutaneous basal-bolus insulin injection for a blood sugar goal 70-110 mg/dL.
Upon discharge from the hospital, the patient will be placed on a basal-bolus regimen consisting of 3-4 insulin injections to maintain a blood sugar between 70-140.
Active Comparator: Control
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.
Drug: NPH Insulin or glargine insulin and aspartame insulin
The NPH or glargine and aspartame insulin will be given subcutaneously using a small-short needle to administer the insulin.
The blood sugar level will be checked every 1 hour while in the operating room and treated with rapid-acting insulin as needed to keep the blood sugar levels 70-180 mg/dL. The blood sugar level will be checked every 4 hours when in the recovery room and on the 6 East transplant unit. Once the patient is able to eat, the blood sugar will be checked five times a day (before meals, at bedtime, and at 3:00 am). Long-acting and rapid-acting insulin will be used to maintain the target blood sugar level.
Upon discharge from the hospital, the patient will be placed on a minimum of one to two insulin injections to maintain a blood sugar between 90-180 mg/dL
- Delayed Graft Function [ Time Frame: 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 [ Time Frame: 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.
- Severe Hypoglycemia [ Time Frame: 30 months ]Blood glucose less than 40 mg/dl
- Severe Hyperglycemia [ Time Frame: 30 months ]Blood glucose greater than 350 mg/dl.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609986
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29464|
|Principal Investigator:||Kathie L. Hermayer, MD, MS||Medical University of South Carolina, Division of Endocrinology|