IV Insulin Protocol in Diabetes and Renal Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathie Hermayer, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00609986
First received: January 2, 2008
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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 Intervention
Kidney Transplantation
Diabetes
Hyperglycemia
Drug: insulin
Drug: NPH Insulin or glargine insulin and aspartame insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Delayed Graft Function [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    Blood glucose less than 40 mg/dl

  • Severe Hyperglycemia [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    Blood glucose greater than 350 mg/dl.


Enrollment: 104
Study Start Date: July 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive
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.
Drug: insulin

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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609986

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29464
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kathie L. Hermayer, MD, MS Medical University of South Carolina, Division of Endocrinology
  More Information

No publications provided

Responsible Party: Kathie Hermayer, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00609986     History of Changes
Other Study ID Numbers: HR #17383, ADA 7-07-CR-22
Study First Received: January 2, 2008
Results First Received: June 5, 2013
Last Updated: August 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Kidney
Transplantation
Diabetes
Hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014