Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund
Lund, 221 85, Sweden
NCT Number: NCT01423955
The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2
Lund, 221 85, Sweden
Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.
Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.
Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.
The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The active drug will be given only once after the anesthesia induction and before the start of surgery. The active drug will be diluted to 2000U/kg and given as a single dose of 400U/kg. The dose will be prepared prior to surgery by a independent nurse.
Other names: Active substance: Erythropoietin zeta, Drug brand name: Retacrit®, Manufacturer and Provider: Hospira, ATC-code: B03XA01
Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg.
Time frame: 3 days postoperatively
Region Skane
Other
EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.
Acronym: EPRICS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03242343
Aneurysm, Arterio-venous Fistula
Birmingham, Alabama, United States
View Trial DetailsNCT03332186
Cardiac Failure, Cardiovascular Diseases
Prague, Czechia
View Trial DetailsNCT01554982
Chronic Disease, Disease Attributes
Los Angeles, California, United States
View Trial DetailsNCT00765661
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Cincinnati, Ohio, United States
View Trial Details