NCT01423955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

August 24, 2011

Last Update Submit

October 24, 2013

Conditions

Kidney FailureRenal Failure

Keywords

ErythropoietinErythropoetinCardiac surgeryIschemiaReperfusionRenal functionCystatin CCreatinineSafety

Outcome Measures

Primary Outcomes (1)

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

    3 days postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Erythropoietin

EXPERIMENTAL

• 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

Interventions

Erythropoietin zetaDRUG

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.

Also known as: Active substance: Erythropoietin zeta, Drug brand name: Retacrit®, Manufacturer and Provider: Hospira, ATC-code: B03XA01
Erythropoietin
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Renal InsufficiencyIschemia

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henrik Bjursten, M.D. Ph.D

    Region Skane

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2011

First Posted

August 26, 2011

Study Start

October 1, 2011

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

SE(1)