Citrate Versus Heparin Anticoagulation: Effect on Molecules Clearances
Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Septic Shock
Intervention: Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation) (Drug); Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Hospices Civils de Lyon Overall contact: Thomas Rimmelé, Dr, Phone: 4 72 11 02 13, Ext: +33, Email: th.rimmele@gmail.com
Summary
Sepsis is responsible for 50% of all acute kidney injury (AKI) in intensive care units
(ICUs), contributing greatly to multiple organ dysfunction syndrome (MODS). Special types of
continuous renal replacement therapies (CRRT) have been proposed as adjuvant therapies for
septic shock due to their ability to remove middle molecular weight molecules such as
inflammatory mediators involved in MODS pathophysiology. These therapies are called
extracorporeal " blood purification " therapies.
When CRRT is used, an anticoagulation is required to prevent clotting of the extracorporeal
circuit, possibly causing bleeding in selected patients. Many anticoagulation strategies
have been proposed and the most commonly used in 2013 is still unfractionated heparin.
Regional citrate anticoagulation (RCA) is an interesting alternative as it dramatically
decreases the bleeding risk.
The investigators hypothesize that the use of citrate with Super High Flux Continuous
Veno-Venus Hemodialysis (SHF-CVVHD) would be highly beneficial over time by preserving the
filter effectiveness via limiting protein adhesion (which subsequently reduces filter pore
sizes (protein cake)), as compared to heparin. Consequently, higher clearances of the
inflammatory mediators could be maintained over time with citrate as compared to heparin
anticoagulation. In other words, for the same duration of filter use, middle molecular
weight molecules and cytokines clearances would be greater with citrate as compared to
heparin. To test this hypothesis, the investigators will perform a clinical randomized
controlled trial which aim would be to compare middle molecular weight molecules and
cytokines clearances in SHF-CVVHD using RCA versus systemic heparin anticoagulation in
septic patients with AKI.
Clinical Details
Official title: Regional Citrate Versus Systemic Heparin Anticoagulation for Super High-flux Continuous Hemodialysis in Septic Shock: Effect on Middle Molecular Weight Molecules Clearances
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Middle molecular weight molecules clearances
Secondary outcome: Clearances of cytokines and molecules of interestHemodynamic parameters Respiratory parameters mortality
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female critically ill patients over the age of 18 years old
- Acute Kidney Injury requiring CRRT defined using the Risk, Injury, Failure, Loss,
End-stage renal disease (RIFLE) classification with criterion I or worse.
- Septic shock as defined by the American College of Chest Physicians/Society of
Critical Care Medicine Consensus Conference.
- Written informed consent obtained from the patient or a patient's legal
representative
- Patient patient's legal representative able to agree to patient's enrollment in the
study with informed consent.
Exclusion Criteria:
- Pregnancy
- Participation in another research study protocol
- Known heparin induced thrombopenia or contraindication to heparin
- Pre-existing chronic renal failure on chronic dialysis
- Therapeutic anticoagulation with heparin for another reason (e. g. chonic arrhythmia)
- Severe liver failure (15% prothrombin time)
Locations and Contacts
Thomas Rimmelé, Dr, Phone: 4 72 11 02 13, Ext: +33, Email: th.rimmele@gmail.com
Service de Réanimation - Pavillon P, Hôpital Edouard Herriot, Lyon 69003, France; Recruiting Thomas Rimmelé, Dr, Phone: 4 72 11 02 13, Ext: +33, Email: th.rimmele@gmail.com Bernard Allaouchiche, Pr, Phone: 4 72 11 02 13, Ext: +33, Email: bernard.allaouchiche@chu-lyon.fr Thomas Rimmelé, Dr, Principal Investigator Bernard Allaouchiche, Pr, Sub-Investigator Charles-Eric Ber, Dr, Sub-Investigator Jullien Crozon, Dr, Sub-Investigator Mathieu Page, Dr, Sub-Investigator Johanne Prothet, Dr, Sub-Investigator Jean-Jacques Baillon, Dr, Sub-Investigator Françoise Christin, Dr, Sub-Investigator Bernard Floccard, Dr, Sub-Investigator Christian Guillaume, Dr, Sub-Investigator Olivier Martin, Dr, Sub-Investigator Guillaume Marcotte, Dr, Sub-Investigator Etienne Hautin, Dr, Sub-Investigator Alexandre Faure, Dr, Sub-Investigator Thomas Geffriaud, Dr, Sub-Investigator François Malavieille, Dr, Sub-Investigator
Additional Information
Starting date: May 2013
Last updated: August 26, 2014
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