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Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis (BEERT)

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01560364
First received: October 17, 2011
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.


Condition Intervention
Adults Receiving Renal Replacement Therapy
 Other: renal replacement therapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Hemofilter lifetime [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemofilter clotting risk factors [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • hemofiltration duration [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • down time value [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hemofilter Other: renal replacement therapy
Prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.

Detailed Description:

Prospective before / after observational clinical multicentric study on ICU acute kidney injury during renal replacement therapy. Evaluation of incidence and exposure to hemofilter clotting.

The after phase will consist in medical measures (help for prescription) and paramedical measures (stop the filtration flow during the patient's mobilization).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults receiving renal replacement therapy

Criteria

Inclusion Criteria:

  • Adult (age > 18 years)
  • Renal replacement therapy (continuous veino-veinous hemofiltration or continuous veino-veinous hemodiafiltration)
  • Consent of patients

Exclusion Criteria:

  • Use citrate anticoagulation
  • Age below 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560364

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Sébastien PERBET University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01560364     History of Changes
Other Study ID Numbers: CHU-0106
Study First Received: October 17, 2011
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Renal replacement therapy
Hemofilter clotting
Clotting risk factor
Hemofilter clotting prevention

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013