Status:
RECRUITING
IHD Versus CRRT for Severe Acute Kidney Injury in Critically Ill Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 I...
Detailed Description
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 I...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06032884
Start Date
October 28 2023
End Date
January 28 2026
Last Update
December 5 2024
Active Locations (1)
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1
c 001 Avicenne Service de réanimation médico chirurgicale
Bobigny, France, 93000