IHD Versus CRRT for Severe Acute Kidney Injury in Critically Ill Patients

Recruiting now · Not applicable

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID: NCT06032884
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 1000
Starts: 2023-10-28
Expected to finish: 2026-01-28
Last updated by the study team: 2024-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults (> or= 18 years old) in ICU
Receiving (or who have received) invasive mechanical ventilation and/or catecholamine infusion
Availability of both equipment IHD and CRRT (in the investigational center at the time of inclusion)
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)
Affiliation of social security system
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

You may not qualify if…

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

Where it is running

c 001 Avicenne Service de réanimation médico chirurgicale — Bobigny, France (enrolling)

Full record on ClinicalTrials.gov

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