Comparing two kidney treatment methods for critically ill patients
Intermittent Hemodialysis Versus Continuous Renal Replacement Therapy for Severe Acute Kidney Injury in Critically Ill Patients
This study is testing whether a new kidney treatment called intermittent hemodialysis works just as well as continuous renal replacement therapy for critically ill patients with severe kidney injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny) |
| Trial ID | NCT06032884 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intermittent hemodialysis (IHD) compared to continuous renal replacement therapy (CRRT) in critically ill patients suffering from severe acute kidney injury (AKI). The study will assess whether IHD is not inferior to CRRT in terms of a composite outcome that includes death, persistent renal dysfunction, and dialysis dependency at 90 days post-treatment. By focusing on recent advancements in renal replacement therapy initiation strategies, the trial seeks to provide updated insights into the best treatment approach for this patient population. Participants will be randomly assigned to receive either IHD or CRRT based on specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are in the ICU and experiencing severe acute kidney injury requiring renal replacement therapy.
Not a fit: Patients who do not have severe acute kidney injury or those who are not critically ill may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective renal replacement therapy for critically ill patients with severe AKI, potentially improving patient outcomes.
How similar studies have performed: Previous studies comparing IHD and CRRT have not shown a clear advantage for either method, but this trial aims to address gaps in knowledge with updated methodologies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bobigny
- c 001 Avicenne Service de réanimation médico chirurgicale — Bobigny, France (Recruiting)
Study contacts
- Study coordinator: Stéphane GAUDRY, Pr,MD, PhD
- Email: stephane.gaudry@aphp.fr
- Phone: 01.48.95.22.81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.