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Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery (EPRICS)

This study is currently recruiting participants.
Verified September 2012 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01423955
First received: August 24, 2011
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Kidney Failure
Renal Failure
 Drug: Erythropoietin zeta
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Change in plasma cystatin C measured on day 3 postoperatively. [ Time Frame: 3 days postoperatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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.
 Drug: Placebo
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.
Experimental: Erythropoietin
• Active substance: Erythropoietin zeta with the ATC-code: B03XA01. The drug is a Clear colorless solution for injection. The active substance will be diluted with NaCl 9mg/ml to a to a concentration of 2000 U/ml. A dose of 400U/kg will be prepared and marked before the operation. The drug will be administrated after the anesthesia induction and before the start of surgery.
 Drug: Erythropoietin zeta
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423955

Locations
Sweden
Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund Recruiting
Lund, Sweden, 221 85
Contact: Henrik Bjursten, M.D. Ph.D.     +4646175349     Henrik.Bjursten@med.lu.se    
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Henrik Bjursten, M.D. Ph.D Region Skane
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01423955     History of Changes
Other Study ID Numbers: 2011-001673-70
Study First Received: August 24, 2011
Last Updated: September 4, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Region Skane:
Erythropoietin
Erythropoetin
Cardiac surgery
Ischemia
Reperfusion
 Renal function
Cystatin C
Creatinine
Safety

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
 Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013