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| Sponsored by: |
Catholic University of the Sacred Heart |
|---|---|
| Information provided by: | Catholic University of the Sacred Heart |
| ClinicalTrials.gov Identifier: | NCT00890214 |
Purpose
The researchers investigated the influence of a prostacyclin analogue (PGIA) versus unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous hemodiafiltration.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Kidney Failure |
Drug: prostacyclin Drug: heparin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Heparin Versus Prostacyclin in Continuous Hemodiafiltration for Acute Renal Failure: Effects on Platelet Responsiveness in the Systemic Circulation and Across the Filter. |
| Enrollment: | 23 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1 prostacyclin group: Active Comparator
prostacyclin analogue (PGIA) used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
|
Drug: prostacyclin
prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min
|
|
2 heparin group: Active Comparator
unfractionated heparin used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
|
Drug: 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.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Policlinico Gemelli | |
| Rome, Italy, 00168 | |
| Study Director: | Massimo Antonelli, MD | Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli |
More Information
| Responsible Party: | Istituto di Anestesia e Rianimazione ( Massimo Antonelli ) |
| Study ID Numbers: | AABR-0609 |
| Study First Received: | April 23, 2009 |
| Last Updated: | April 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00890214 History of Changes |
| Health Authority: | Italy: National Bioethics Committee; Italy: National Institute of Health |
|
Anticoagulation Prostacyclin Heparin |
Renal Replacement Therapy Kidney failure acute Platelet aggregation |
|
Renal Insufficiency Anticoagulants Heparin, Low-Molecular-Weight Fibrinolytic Agents Cardiovascular Agents Antihypertensive Agents Calcium heparin Calcium, Dietary Fibrin Modulating Agents |
Urologic Diseases Epoprostenol Platelet Aggregation Inhibitors Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Heparin Kidney Failure |
|
Renal Insufficiency Anticoagulants Molecular Mechanisms of Pharmacological Action Heparin, Low-Molecular-Weight Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Calcium heparin |
Fibrin Modulating Agents Urologic Diseases Therapeutic Uses Epoprostenol Platelet Aggregation Inhibitors Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Heparin Kidney Failure |
