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Completed

NCT Number: NCT01423955

Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund

Lund, 221 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is scheduled for non-emergent CABG surgery.
  • CyC eGFR or MDRD eGFR < 60 ml/min.
  • The patient has given his/her written consent to participate

Exclusion criteria

  • The patient has an uncontrolled hypertension.
  • Hypersensitivity to the active drug.
  • The patient is pregnant or is a fertile woman (<50 years).
  • The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
  • Preoperative CyC eGFR or MDRD eGFR is < 15, or the patient is treated with dialysis.
  • The patient has a known malignancy.
  • The patient is planned for Off-pump CABG surgery.
  • The patient is included in other ongoing clinical trial. Yes / No
  • Clinically judgment by the investigator that the patient should not participate in the study.

Treatment and study plan

Erythropoietin zeta

Drug

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

Drug

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.

Primary outcomes

  1. Change in plasma cystatin C measured on day 3 postoperatively.

    Time frame: 3 days postoperatively

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.

Acronym: EPRICS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 26, 2011
Registry last updated
Oct 25, 2013

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.

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