Early Intervention in Acute Renal Failure

A multi-site randomised phase IV study to evaluate the effectiveness of intravenous erythropoietin in preventing intensive care unit patients with acute kidney injury from developing acute renal failure.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000058572

Acronym

EARLY ARF 2

Enrollment

130

Registered

2006-02-09

Start date

2006-01-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients admitted to a general intensive care unit and high risk post cardiothoracic surgery patients will be screened for renal injury using urinary biomarkers and randomised within 6 hours of admission to two doses of placebo or erythropoietin at 24 hour intervals. Subjects, investigators and treating clinicians will be blinded to treatment throughout the study.

Interventions

Intravenous Erythropoietin in 2 doses at 0 and 24 hours after the detection of a raised urinary acute kidney injury index

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Gamma Glutamyl Transpeptidase X Alkaline Phosphatase index of >46.3 u/mmol. 2. Likely survival >72 hours. 3. Consent obtained.

Exclusion criteria

1. Active cytotoxic chemotherapy in progress2. Pre existing renal disease (serum creatinine >0.345 mmol/L)3. presence of rhabdomyolysis and/or myoglobinuria4. Already enrolled in another interventional study or previously enrolled in this study5. Increase of plasma creatinine of > 43 µmol/L over the previous 24 hours.

Outcome results