Hyperglycemia in Renal Transplantation (HiRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01643382
First received: July 16, 2012
Last updated: February 1, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Diabetes
End Stage Renal Disease
Drug: Insulin
Drug: Insulin, Asp(B28)-

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • incidence of poor graft function after kidney transplant [ Time Frame: 7 days after transplant ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tight glucose control
Patients randomized to the tight glucose control arm will be placed on an insulin infusion, or continuous low dose insulin drip.
Drug: Insulin
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
Active Comparator: Standard glucose control
Patients randomized to the standard glucose control group will be given subcutaneous doses of insulin every few hours based on their blood sugar.
Drug: Insulin, Asp(B28)-
Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients
  • diabetic
  • end stage renal disease undergoing cadaveric renal transplant

Exclusion Criteria:

  • enrolled in concurrent study to test impact of a drug on graft function after transplant
  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: NCT01643382

Contacts
Contact: Justin Parekh, MD, MAS 415-595-3707 justin.parekh@ucsfmedctr.org

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94123
Contact: Justin R Parekh, MD,MAS    415-353-8780    justin.parekh@ucsfmedctr.org   
Contact: Ryutaro Hirose, MD    415-353-8783    ryutaro.hirose@ucsfmedctr.org   
Principal Investigator: Justin Parekh, MD         
Sub-Investigator: Ryutaro Hirose, MD         
Sub-Investigator: Robert Rushakoff, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Justin Parekh, MD, MAS UCSF Department of Surgery
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01643382     History of Changes
Other Study ID Numbers: HiRT 042918
Study First Received: July 16, 2012
Last Updated: February 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
diabetes
kidney transplant
end stage renal disease
delayed draft function

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014