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

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00993733
• Other study ID #: 1008019
• Secondary ID: 2010-A00695-34
• Status: Withdrawn
• Phase: N/A
• First received: October 9, 2009
• Last updated: March 22, 2016
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Procedure:
• Continuous veno-venous haemodiafiltration
Dialysis procedure administrated to the patients with acute renal failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	costs of CVVHDF performed using a conventional and on-line methods	The end of the study for the patient corresponds to the end of CVVHDF conventional and on line.	Day 1	No