Hyperglycemia in Renal Transplantation

Diabetes Clinical Trial

— HiRT  

Official title:

Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643382
• Other study ID #: HiRT 042918
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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
• Insulin, Asp(B28)-
Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (3)

Parekh J, Bostrom A, Feng S. Diabetes mellitus: a risk factor for delayed graft function after deceased donor kidney transplantation. Am J Transplant. 2010 Feb;10(2):298-303. doi: 10.1111/j.1600-6143.2009.02936.x. Epub 2010 Jan 6. — View Citation

Parekh J, Niemann CU, Dang K, Hirose R. Intraoperative hyperglycemia augments ischemia reperfusion injury in renal transplantation: a prospective study. J Transplant. 2011;2011:652458. doi: 10.1155/2011/652458. Epub 2011 Sep 4. — View Citation

Parekh J, Roll GR, Wisel S, Rushakoff RJ, Hirose R. Effect of moderately intense perioperative glucose control on renal allograft function: a pilot randomized controlled trial in renal transplantation. Clin Transplant. 2016 Oct;30(10):1242-1249. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Poor Graft Function After Kidney Transplant	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)	7 days after transplant