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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 interest

Hemodynamic 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

Page last updated: August 23, 2015

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