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Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care

This study has been withdrawn prior to enrollment.
(This study has never been started)
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00993733
First received: October 9, 2009
Last updated: January 31, 2011
Last verified: January 2011
History of Changes
  Purpose

The prevalence of acute renal failure in intensive care is estimated at between 5 and 20% depending on diagnostic criteria retained. And half of patients require the use of hemodialysis. Continuous veno-venous hemodiafiltration (CVVHDF) is one of the hemodialysis technique widely used in intensive care unit.

The CVVHDF is performed at the bedside, by a mobile generator with a semi permeable membrane, a blood circuit, a dialysate circuit and a feedback circuit.

The implementation of a CVVHDF requires the use of large amounts of biological liquid essential to enable the purification of blood during its passage through the artificial kidney. The biological fluid may be supplied to the generator of CVVHDF in 2 ways:

  • The conventional method, the most used: the generator operates with pockets containing dialysis fluid, these pockets to be changed regularly by nurses
  • The on-line method: the generator operates with a specific water system supplying the dialysis fluid available in every room of the unit The objective of this study is to assess time nursing work and the costs of each method.

For this, 15 patients will be included in this study. Each patient performs 12 hours of each method (conventional and online), whose order will be randomized.


Condition Intervention
Acute Renal Failure
 Procedure: Continuous veno-venous haemodiafiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • time of nursing work required to realised a CVVHDF as a conventional and on line methods modality of supply compared to a method on-line [ Time Frame: End of CVVHDF conventional and on line ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • costs of CVVHDF performed using a conventional and on-line methods [ Time Frame: End of CVVHDF conventional and on line ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CVVHDF on-line
CVVHDF using a central water treatment plant, providing dialysate directly to the patient.
 Procedure: Continuous veno-venous haemodiafiltration
Dialysis procedure administrated to the patients with acute renal failure
Other Names:
  • Classical CVVHDF : dialusate generator Prismaflex (HOSPAL)
  • CVVHDF on-line : dialysate generator 5008 (Fresenius)
Experimental: classical CVVHDF
CVVHDF using a mobile generator with dialysate bags
 Procedure: Continuous veno-venous haemodiafiltration
Dialysis procedure administrated to the patients with acute renal failure
Other Names:
  • Classical CVVHDF : dialusate generator Prismaflex (HOSPAL)
  • CVVHDF on-line : dialysate generator 5008 (Fresenius)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient affiliated with or beneficiary of a social security category
  • Patient with a renal failure requiring a CVVHDF for at least 2 cycles of 12 hours

Exclusion Criteria:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993733

Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Manolie Mehdi, MD CHU Saint Etienne
  More Information

No publications provided

Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00993733     History of Changes
Other Study ID Numbers: 1008019
Study First Received: October 9, 2009
Last Updated: January 31, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
hemodiafiltration
cost
dialysis solution
acute renal failure
intensive care unit

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013