Hyperglycemia in Renal Transplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2012 |
| End Date: | August 2020 |
| Contact: | Justin Parekh, MD, MAS |
| Email: | justin.parekh@ucsfmedctr.org |
| Phone: | 415-595-3707 |
Randomized Study of the Impact of Peri-operative Glucose Control on Short Term Renal Allograft Function After Transplantation
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.
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.
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.
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.
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
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