Prostacyclin's Effect on Platelet Responsiveness

Acute Kidney Failure Clinical Trial

Official title:

Heparin Versus Prostacyclin in Continuous Hemodiafiltration for Acute Renal Failure: Effects on Platelet Responsiveness in the Systemic Circulation and Across the Filter.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890214
• Other study ID #: AABR-0609
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2009
• Last updated: April 28, 2009
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: April 2009
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics CommitteeItaly: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

The researchers investigated the influence of a prostacyclin analogue (PGIA) versus unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous hemodiafiltration.

Description:

Context and purpose of the study: Prospective, randomized comparison of a PGIA versus UFH as circuit anticoagulant. Platelet responsiveness was assessed from peripheral blood by light-transmittance aggregometry (LTA) induced by collagen and ADP, at baseline, 4 and 24 hrs after treatment onset. Platelet function was also assessed in blood samples collected in the circuit before and after the filter. The Setting was a University Hospital Intensive Care Unit. 23 ICU patients with Acute Renal Failure needing CVVHDF were studied during standard CVVHDF therapy, at random infusion in the extracorporeal circuit of PGIA or UFH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• critically patients ill patients with acute kidney failure (AKI) needing renal replacement therapy

Exclusion Criteria:

• therapy with aspirin or other non-steroidal anti-inflammatory drugs in the previous 7 days

• concomitant treatment with other extracorporeal organ-assist devices any other drug affecting coagulation or platelets

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

Drug:
• prostacyclin
prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min
• heparin
was prepared using our standard protocol: 2 ml of an already-stored solution containing 5000 IU/ml of UFH were diluted in 20 ml of saline obtaining a final concentration of 500 IU/ml, and infused pre-filter at 6 IU/Kg/h, according to the post-filter activated clotting time measured hourly, and adjusted to obtain a value between 180 and 200 sec.

Locations

Country	Name	City	State
Italy	Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy,