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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00993733
Collaborator
(none)
0
2
12

Study Details

Study Description

Brief Summary

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 objective of this study is to assess time nursing work and the costs of each method.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Continuous veno-venous haemodiafiltration
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Assessing the Impact of Two Methods of Continuous Veno-venous Hemodiafiltration on Time Nursing Work in Intensive Care
Study Start Date :
Sep 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2011
Anticipated Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: CVVHDF on-line

CVVHDF using a central water treatment plant, providing dialysate directly to the patient. They will perform a continuous veno-venous haemodiafiltration.

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. They will perform a continuous veno-venous haemodiafiltration.

    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)
  • Outcome Measures

    Primary Outcome Measures

    1. 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 [Day 1]

      The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.

    Secondary Outcome Measures

    1. costs of CVVHDF performed using a conventional and on-line methods [Day 1]

      The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne

    Investigators

    • Principal Investigator: Manolie Mehdi, MD, CHU Saint Etienne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT00993733
    Other Study ID Numbers:
    • 1008019
    • 2010-A00695-34
    First Posted:
    Oct 12, 2009
    Last Update Posted:
    Mar 23, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2016