Informations générales (source: ClinicalTrials.gov)
Intermittent Hemodialysis Versus Continuous Renal Replacement Therapy for Severe Acute Kidney Injury in Critically Ill Patients
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2023
janvier 2026
13 août 2025
Intermittent hemodialysis (IHD) and continuous RRT (CRRT) provided as continuous
hemofiltration or hemodiafiltration are the main RRT modalities in ICU. Randomized
controlled trials (RCTs) comparing IHD and CRRT for AKI have not shown an indisputable
benefit of one technique over the other. However, these studies were conducted more than
15 years ago. In addition, several recent RCTs on RRT initiation strategies have
completely modified both knowledge and practice of RRT initiation.
The main objective is to evaluate whether IHD is not inferior to CRRT with regard to
overall incidence of a composite outcome of death, persistent renal dysfunction and
dialysis dependency at day 90 in critically ill patients with severe AKI (Major Kidney
Event 90, MAKE 90). The primary endpoint will be the proportion of patients who will meet
one or more criteria for a major adverse kidney event 90 days after randomization
(MAKE90). The MAKE will be the composite of death, renal replacement therapy dependence
and/or an increase in serum creatinine above 25% of its basal value.
This is a non-inferiority multicenter open-label randomized controlled trial with two
parallel groups. Randomization will take place 1:1 to 2 groups: a group receiving IHD and
a group receiving CRRT. Randomization will be stratified according to center, dose of
vasopressor and cumulative fluid balance from ICU admission. Treatment will be initiated
and monitored by the physician responsible for patient. Whatever the group, investigators
will follow recommendations to achieve optimal metabolic control and hemodynamic
stability. The investigators plan to include 1000 patients.
Etablissements
Critères
Tous
Inclusion Criteria:
1. Adults (> or= 18 years old) in ICU
2. Receiving (or who have received) invasive mechanical ventilation and/or
catecholamine infusion
3. Availability of both equipment IHD and CRRT (in the investigational center at the
time of inclusion)
4. One of the 2 following situations 4.a: Either at least one of the 3 following
complications of AKI* (whatever the KDIGO stage): persistent severe hyperkalaemia
despite medical treatment, persistent severe metabolic acidosis despite medical
treatment or severe pulmonary edema due to fluid overload despite diuretic therapy
4.b: Or an AKI stage 3 of KDIGO with one of the 2 following criteria: serum urea
concentration>40mmol/L or persistence of oligo-anuria>3 days
*Definitions of these complication are provided in the main text (Section 7.1)
5. Affiliation of social security system
6. Written consent obtained from the patients (from a support person, family member or
a close relative if the patient is not able to expressing and sign consent) or
inclusion without initial consent in case of emergency, if the patient is not able
to express his/her consent and in the absence of support person, family member or a
close relative
1. Adults (> or= 18 years old) in ICU
2. Receiving (or who have received) invasive mechanical ventilation and/or
catecholamine infusion
3. Availability of both equipment IHD and CRRT (in the investigational center at the
time of inclusion)
4. One of the 2 following situations 4.a: Either at least one of the 3 following
complications of AKI* (whatever the KDIGO stage): persistent severe hyperkalaemia
despite medical treatment, persistent severe metabolic acidosis despite medical
treatment or severe pulmonary edema due to fluid overload despite diuretic therapy
4.b: Or an AKI stage 3 of KDIGO with one of the 2 following criteria: serum urea
concentration>40mmol/L or persistence of oligo-anuria>3 days
*Definitions of these complication are provided in the main text (Section 7.1)
5. Affiliation of social security system
6. Written consent obtained from the patients (from a support person, family member or
a close relative if the patient is not able to expressing and sign consent) or
inclusion without initial consent in case of emergency, if the patient is not able
to express his/her consent and in the absence of support person, family member or a
close relative
- Moribund state (patient likely to die within 24h)
- Previous inclusion in the study
- Subject deprived of freedom, or under a legal protective measure (example: patients
under guardianship or curatorship)
- Subject receiving state medical aid
- Pregnancy or breastfeeding woman
- Patient included in another research trial on AKI
- Advanced chronic kidney disease (CKD) defined by an estimated GFR<20 mL/min/1.73 m2
- Presence of a drug overdose or of a dialyzable toxin that necessitates RRT (because
IHD may be preferable in these conditions).
- Presence or clinical suspicion of renal obstruction, rapidly progressive
glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial
nephritis
- Brain injured patients or other causes of increased intracranial pressure
- Fulminant hepatic failure