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

Primary Purpose

Kidney Failure, Renal Failure

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Erythropoietin zeta
Placebo
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Erythropoietin, Erythropoetin, Cardiac surgery, Ischemia, Reperfusion, Renal function, Cystatin C, Creatinine, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Erythropoietin

Arm Description

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.

• 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.

Outcomes

Primary Outcome Measures

Change in plasma cystatin C measured on day 3 postoperatively.

Secondary Outcome Measures

Full Information

First Posted
August 24, 2011
Last Updated
October 24, 2013
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT01423955
Brief Title
Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery
Acronym
EPRICS
Official Title
EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Renal Failure
Keywords
Erythropoietin, Erythropoetin, Cardiac surgery, Ischemia, Reperfusion, Renal function, Cystatin C, Creatinine, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Erythropoietin
Arm Type
Experimental
Arm Description
• 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.
Intervention Type
Drug
Intervention Name(s)
Erythropoietin zeta
Other Intervention Name(s)
Active substance: Erythropoietin zeta, Drug brand name: Retacrit®, Manufacturer and Provider: Hospira, ATC-code: B03XA01
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Change in plasma cystatin C measured on day 3 postoperatively.
Time Frame
3 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Bjursten, M.D. Ph.D
Organizational Affiliation
Region Skane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

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Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

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