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

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ClinicalTrials.gov Identifier: NCT00993733
Recruitment Status : Withdrawn (This study has never been started)
First Posted : October 12, 2009
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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
Acute Renal Failure Procedure: Continuous veno-venous haemodiafiltration Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

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)




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 [ Time Frame: 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 [ Time Frame: Day 1 ]
    The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:


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): NCT00993733


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

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00993733     History of Changes
Other Study ID Numbers: 1008019
2010-A00695-34 ( Other Identifier: AFSSAPS )
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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