Erythopoietin and delayed graft function in renal allografts from extended criteria donors

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: During implantation of the kidney, after the vascular anastamosis, but prior to clamp release, an intravenous bolus dose of EPO (33,000 iu) or placebo will be administered by the anaesthetist through the central line immediately before the surgeon opens the clamps to allow blood flow into the kidney. An intravenous bolus dose of EPO (33,000 iu) or placebo will be administered to the patient 24 hours and 48 hours following the first 'in surgery' dose. CONDITION: Renal transplantation ; Surgery ; Other complications of surgical and medical care, not elsewhere classified PRIMARY OUTCOME: Comparison of plasma and urine levels of biomarkers of acute kidney injury (NGAL, IL‐18, HGF, FABP1) between the treatment and placebo groups during the immediate post‐operative period SECONDARY OUTCOME: 1. Comparison of the incidence and severity of delayed graft function and acute rejection between the two arms of the study in the early post‐operative period; 2. Kidney function using standard clinical parameters will be monitored post‐operatively, and at 3, 6, 9 and 12 months INCLUSION CRITERIA: 1. Men and women aged greater than or equal to 18 years 2. The subject is willing to provide signed written informed consent 3. The subject is the recipient of a deceased donor kidney transplant 4. The donor and/or donor kidney meet at least one of the following extended criteria for organ donation from either 4.1. or 4.2. as described below: 4.1. Donor: Greater than 50 years with: 4.1.1. Cerebrovascular accident (CVA) + hypertension (HTN) + serum creatinine (SCr) greater than 1.5 4.1.2. CVA + HTN 4.1.3. CVA + SCr greater than 1.5 4.1.4. HTN + SCr greater than 1.5 Greater than 60 years with: 4.1.5. CVA 4.1.6. HTN 4.1.7. SCr greater than 1.5 4.2. Additional criteria cold ischaemia time (CIT) greater than or equal to 24 hours
Epistemonikos ID: c01e306eb2facdc251d139ec9185effdcdedf11f
First added on: Aug 22, 2024