Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 108 for:    CALCIUM CATION

Citrate Versus Heparin Anticoagulation: Effect on Molecules Clearances (RCA-SHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01839578
Recruitment Status : Unknown
Verified August 2014 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : April 25, 2013
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Septic Shock Drug: Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation) Drug: Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RCA Group
SHF-CVVHD with regional citrate anticoagulation
Drug: Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation)

Anticoagulation to prevent clotting of the extracorporeal circuit. Unfractionated heparin and regional citrate anticoagulation will be compared.

Ci-Ca protocole for MultiFiltrate® CRRT machine :

  • 4% trisodium citrate solution
  • Calcium chloride solution (100 mmol/L)
  • Dialysate flow rate: 35 ml/kg/h
  • Blood flow rate: adjusted to maintain a ratio blood flow rate / dialysate flow rate of 3
  • Citrate infusion titrated to maintain postfilter ionized calcium between 0.25 and 0.35 mmol/L.
  • Calcium chloride infusion titrated to maintain systemic ionized calcium between 1.12 and 1.2 mmol/L.
  • Blood flow adapted to the acid-base status

Experimental: Heparin group
SHF-CVVHD with systemic heparin anticoagulation
Drug: Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin)

Anticoagulation to prevent clotting of the extracorporeal circuit. Unfractionated heparin and regional citrate anticoagulation will be compared.

  • Continuous infusion of unfractionated heparin: starting infusion rate at 600 IU/h then adjusted to maintain partial thromboplastin time at 1-1.4 times the normal value.
  • Standard dialysate for CRRT : Prismasol® K2 solution
  • Dialysate flow rate: 35 ml/kg/h
  • Blood flow rate: adjusted to maintain a ratio blood flow rate / dialysate flow rate of




Primary Outcome Measures :
  1. Middle molecular weight molecules clearances [ Time Frame: 18 months ]
    At each time point of the study (T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h), blood and post-filter samplings will be taken in order to calculate kappa and lambda light chains of immunoglobulin clearances.


Secondary Outcome Measures :
  1. Clearances of cytokines and molecules of interest [ Time Frame: T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h ]
    At each time point of the study (T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h), sampling will be simultaneously collected from blood and post-filter in order to determine cytokines (IL-1 ra, IL-10, IL-6, IL-8, β2microglobuline), urea, creatinine and albumin clearances.

  2. Hemodynamic parameters [ Time Frame: T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h ]
    At each time point of the study (T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h), clinical data and blood sampling will be collected in order to assess mean arterial pressure, heart rate, vasopressor requirement and lactate level.

  3. Respiratory parameters [ Time Frame: (T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h), ]
    At each time point of the study (T=1h,T=4h,T=12h,T=24h, T=48h, and T=72h), PaO2/FIO2 ratio will be measured by blood sampling and clinical data collection.

  4. mortality [ Time Frame: 28th day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839578


Contacts
Layout table for location contacts
Contact: Thomas Rimmelé, Dr 4 72 11 02 13 ext +33 th.rimmele@gmail.com
Contact: Pr Bernard Allaouchiche, Pr 4 72 11 02 13 ext +33 bernard.allaouchiche@chu-lyon.fr

Locations
Layout table for location information
France
Service de Réanimation - Pavillon P, Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Thomas Rimmelé, Dr    4 72 11 02 13 ext +33    th.rimmele@gmail.com   
Contact: Bernard Allaouchiche, Pr    4 72 11 02 13 ext +33    bernard.allaouchiche@chu-lyon.fr   
Principal Investigator: Thomas Rimmelé, Dr         
Sub-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         
Sponsors and Collaborators
Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01839578     History of Changes
Other Study ID Numbers: 2012.724
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014
Keywords provided by Hospices Civils de Lyon:
cytokines
blood purification
super high flux hemodialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Calcium heparin
Calcium Chelating Agents
Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Heparin
Citric Acid
Sodium Citrate
Anticoagulants
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents