Clinical trial NCT01643382: Hyperglycemia in Renal Transplantation
Official title: Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
End Stage Renal Disease
Keywords: diabetes
kidney transplant
end stage renal disease
delayed draft function
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Incidence of Poor Graft Function After Kidney Transplant
timeFrame: 7 days after transplant
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: UCSF Department of Surgery
name: Justin Parekh, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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: 10.1111/ctr.12811. Epub 2016 Sep 24.
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.