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

Primary Purpose

Renal Failure, Acute

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hemodiafiltration first
Hemofiltration first
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1 (hemodiafiltration first)

Group 2 (hemofiltration first)

Arm Description

This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.

This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Urea clearance (ml/min) for the dialysis sequence under study
Urea clearance (ml/min) for the dialysis sequence under study.
Filter lifespan (hours) for the dialysis sequence under study.
Filter lifespan (hours) for the dialysis sequence under study.
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
Fluid replacement (yes/no)
Was fluid replacement necessary during the studied dialysis sequence?
Fluid replacement (yes/no)
Was fluid replacement necessary during the studied dialysis sequence?

Full Information

First Posted
July 25, 2011
Last Updated
March 26, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01403220
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (hemodiafiltration first)
Arm Type
Active Comparator
Arm Description
This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
Arm Title
Group 2 (hemofiltration first)
Arm Type
Active Comparator
Arm Description
This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.
Intervention Type
Procedure
Intervention Name(s)
Hemodiafiltration first
Intervention Description
Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
Intervention Type
Procedure
Intervention Name(s)
Hemofiltration first
Intervention Description
Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.
Primary Outcome Measure Information:
Title
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
Description
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.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.
Description
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.
Time Frame
24 hours
Title
Urea clearance (ml/min) for the dialysis sequence under study
Description
Urea clearance (ml/min) for the dialysis sequence under study.
Time Frame
12 hours
Title
Filter lifespan (hours) for the dialysis sequence under study.
Description
Filter lifespan (hours) for the dialysis sequence under study.
Time Frame
12 hours.
Title
The percentage down-time for the first 24 hours of dialysis
Description
The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)*100
Time Frame
24 hours
Title
Fluid replacement (yes/no)
Description
Was fluid replacement necessary during the studied dialysis sequence?
Time Frame
12 hours
Title
Fluid replacement (yes/no)
Description
Was fluid replacement necessary during the studied dialysis sequence?
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Jeannes, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28035589
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.
Results Reference
derived
PubMed Identifier
27270279
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.
Results Reference
derived

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

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