NCT06032884 IHD Versus CRRT for Severe Acute Kidney Injury in Critically Ill Patients
| NCT ID | NCT06032884 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-10-28 |
| Primary Completion | 2025-10-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-10-28 with a primary completion date of 2025-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 Exclusion Criteria: * 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
Contact & Investigator
Stéphane GAUDRY
STUDY DIRECTOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06032884 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06032884 currently recruiting?
Yes, NCT06032884 is actively recruiting participants. Contact the research team at stephane.gaudry@aphp.fr for enrollment information.
Where is the NCT06032884 trial being conducted?
This trial is being conducted at Bobigny, France.
Who is sponsoring the NCT06032884 clinical trial?
NCT06032884 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Stéphane GAUDRY at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 1,000 participants.
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