The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care

Renal Failure, Acute Clinical Trial

Official title:

The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403220
• Other study ID #: LOCAL/2011/PJ-02
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: March 26, 2015
• Start date: April 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• According to RIFLE score, patient is stage 'F'

• The patient must be insured or beneficiary of a health insurance plan

• The patient meets at least one of the following criteria:

• metabolic acidosis (pH < 7.2), excluding keto-acidosis

• plasma urea > 25 mmol/l

• hyper-hydration is not controlled by diuretics

Exclusion Criteria:

• Chronic, terminal renal insufficiency with dialysis

• The patient is under judicial protection, under tutorship or curatorship

• Suspect hyperkaliemia (Kaliemia > 6.5 mmol/l with electrocardiographic effects)

• Intoxications treated via dialysis

• Pregnant, lactating, parturient women

• Medical indication for localized citrate anticoagulation

• dialysis of less than 12 h

• patient or representative refuses to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Failure, Acute
• Renal Insufficiency

Intervention

Procedure:
• Hemodiafiltration first
Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
• Hemofiltration first
Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.	Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.	12 hours	No
Secondary	Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.	Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.	24 hours	No
Secondary	Urea clearance (ml/min) for the dialysis sequence under study	Urea clearance (ml/min) for the dialysis sequence under study.	12 hours	No
Secondary	Filter lifespan (hours) for the dialysis sequence under study.	Filter lifespan (hours) for the dialysis sequence under study.	12 hours.	No
Secondary	The percentage down-time for the first 24 hours of dialysis	The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)*100	24 hours	No
Secondary	Fluid replacement (yes/no)	Was fluid replacement necessary during the studied dialysis sequence?	12 hours	Yes
Secondary	Fluid replacement (yes/no)	Was fluid replacement necessary during the studied dialysis sequence?	24 hours	Yes