Clinical trial NCT01403220: The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care
Official title: The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure, Acute
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
timeFrame: 12 hours
Secondary outcomes:
measure: Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
timeFrame: 24 hours
measure: Urea clearance (ml/min) for the dialysis sequence under study
timeFrame: 12 hours
measure: Filter lifespan (hours) for the dialysis sequence under study.
timeFrame: 12 hours.
measure: The percentage down-time for the first 24 hours of dialysis
timeFrame: 24 hours
measure: Fluid replacement (yes/no)
timeFrame: 12 hours
measure: Fluid replacement (yes/no)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pascal Jeannes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Bruggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.
citation: Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.