Clinical trial NCT01364402: Prevention of Contrast Induced Nephropathy by Erythropoietin
Official title: Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes
Chronic Kidney Insufficiency
Keywords: scheduled for PCI
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2011-06-02
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.

The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.

Detailed description: Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).

The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.
* Diabetic patients.
* eGFR \< 60 ml/min/1.73m2.
* Scheduled for primary or elective PCI.

Exclusion Criteria:

* Non diabetic patients.
* Patients with eGFR ≥ 60 ml/min/1.73m2.
* Chronic renal replacement therapy.
* Subject with active malignancy.
* Subject with any known history of seizure disorders.
* Subject with polycythemia.
* Uncontrolled hypertension.
* Known allergy or hypersensitivity to EPO.
* Use of EPO 1 week prior to randomization.
* Use of long acting EPO (CERA) during 1 month prior to randomization.
* Use of NAC or bicarbonate during 3 days prior to randomization.
* Contrast media exposure during the last 7 days before randomization.
* Pregnant or lactating women.
* Participation in other clinical trial.
* Refusal or inability to give informed consent due to mental or physical state.

Primary outcomes:
measure: Incidence of Contrast Induced Nephropathy(CIN)
timeFrame: 1-3 days after exposure to contrast media
Secondary outcomes:
measure: Enzymatic infarct size
timeFrame: 6h and 12 h after exposure to contrast media
measure: Hospital length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Renal replacement therapy
timeFrame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
measure: Hospital mortality
timeFrame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
affiliation: Western Galilee Hospital
name: Shaul Atar, MD
role: PRINCIPAL_INVESTIGATOR
References: