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

NCT00993733 | Withdrawn

• 2 other identifiers: 10080192010-A00695-34
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Renal Failure

Keywords

hemodiafiltration; cost; dialysis solution; acute renal failure; intensive care unit

Outcome Measures

Primary Outcomes (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

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

  Day 1

Secondary Outcomes (1)

• costs of CVVHDF performed using a conventional and on-line methods

  Day 1

Study Arms (2)

CVVHDF on-line

EXPERIMENTAL

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

classical CVVHDF

EXPERIMENTAL

CVVHDF using a mobile generator with dialysate bags. They will perform a continuous veno-venous haemodiafiltration.

Procedure: Continuous veno-venous haemodiafiltration

Interventions

Continuous veno-venous haemodiafiltration PROCEDURE

Dialysis procedure administrated to the patients with acute renal failure

Also known as: Classical CVVHDF : dialusate generator Prismaflex (HOSPAL), CVVHDF on-line : dialysate generator 5008 (Fresenius)

CVVHDF on-line; classical CVVHDF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Manolie Mehdi, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share