Taurolock for Preventing Bacterial Peritonitis During Renal Insufficiency
NCT ID: NCT01101087
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2010-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Taurolock
Taurolock
Placebo
Placebo
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.
Interventions
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Taurolock
Placebo
Injectable sodium chloride conditioned in exactly the same manner as the experimental product.
Eligibility Criteria
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Inclusion Criteria
* Renal insufficiency, stage V (HAS 2007 classification)
* Requires incident peritoneal dialysis
* No signs of peritoneal infection on inclusion
* signed consent
* affiliated with a social security system
Exclusion Criteria
* Survival prognosis for one year is weak
* allergy to citrate, (cyclo)-taurolidine, or heparin
* patient is taking medication with a known contra-indication with citrate or (cyclo)-taurolidine
* patient has a thrombopenia caused by heparin
* impossible to inform the patient correctly
* patient under guardianship
* patient already included in another biomedical research protocol
* no signed consent
* no social security system
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Bernard Branger, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, France
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, , France
CHU de Caen - Hôpital Clemenceau
Caen, , France
CH de Chambéry
Chambéry, , France
CH de Colmar - Hôpitaux Civils de Colmar
Colmar, , France
Association CALYDIAL Vienne
Irigny, , France
Centre Hospitalier Départemental Vendée - Site de la Roche sur Yon
La Roche-sur-Yon, , France
AIDER - Clinque Jacques Mirouze
Montpellier, , France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, , France
CH Pontoise - Centre Hospitalier René Dubos
Pontoise, , France
Association AUB Santé Quimper
Quimper, , France
Centre Hospitalier Regional - Site Groupe Hospitalier Sud Réunion (GHSR)
Saint-Pierre, , France
CH de Valenciennes - Hôpital Jean Bernard et Hôtel Dieu
Valenciennes, , France
ALTIR - Hôpital Brabois
Vandœuvre-lès-Nancy, , France
Association APURAD
Paéa, , French Polynesia
Countries
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Other Identifiers
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2009-A00599-48
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC-N/2009/BB
Identifier Type: -
Identifier Source: org_study_id