Back to resultsIV Insulin Protocol in Diabetes and Renal Transplantation
Primary Purpose
Kidney Transplantation, Diabetes, Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
insulin
NPH Insulin or glargine insulin and aspartame insulin
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplantation focused on measuring Kidney, Transplantation, Diabetes, Hyperglycemia
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive
Control
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Delayed Graft Function
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
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
Severe Hypoglycemia
Blood glucose less than 40 mg/dl
Severe Hyperglycemia
Blood glucose greater than 350 mg/dl.
Full Information
NCT ID
NCT00609986
First Posted
January 2, 2008
Last Updated
August 21, 2013
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00609986
Brief Title
IV Insulin Protocol in Diabetes and Renal Transplantation
Official Title
Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Diabetes, Hyperglycemia
Keywords
Kidney, Transplantation, Diabetes, Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NPH Insulin or glargine insulin and aspartame insulin
Intervention Description
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
Primary Outcome Measure Information:
Title
Delayed Graft Function
Description
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.
Time Frame
10 days
Title
Acute/Active Rejection
Description
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.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Severe Hypoglycemia
Description
Blood glucose less than 40 mg/dl
Time Frame
30 months
Title
Severe Hyperglycemia
Description
Blood glucose greater than 350 mg/dl.
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathie L. Hermayer, MD, MS
Organizational Affiliation
Medical University of South Carolina, Division of Endocrinology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32803882
Citation
Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Results Reference
derived
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IV Insulin Protocol in Diabetes and Renal Transplantation
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