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

NCT06032884 | Recruiting DMC

• 1 other identifier: APHP220811
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; Renal Replacement Therapy; ICU

Outcome Measures

Primary Outcomes (1)

• Major Adverse Kidney Event 90 days after randomization (MAKE90).

  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, RRT dependence and/or more than a 25% increase in serum creatinine from baseline value. Baseline value of serum creatinine will be determined by either results of a measurement in the 12 months preceding the ICU stay or estimation using the Modification of Diet in Renal Disease (MDRD) study equation assuming that baseline eGFR is 75 ml/min per 1.73m2

  90 days after randomization

Secondary Outcomes (11)

• Mortality

  28,60 and 90 days after randomization

• 25% increase in serum creatinine from baseline

  28, 60 and 90 days after randomization

• Dialysis dependency

  28, 60 and 90 days after randomization

• ICU and hospital length of stay

  ICU discharge until 90 days after randomization

• Time until RRT cessation

  90 days after randomization

Study Arms (2)

IHD Group

EXPERIMENTAL

A central venous access (uncuffed nontunneled catheter, preferentially in the right jugular vein or femoral vein), a biocompatible membrane and bicarbonate dialysate will be used. The investigators will plan at least 3 sessions of 4 to 6 hours each per week with blood flow \> 200ml/min, dialysate flow\>500ml/min, high sodium concentration (\>145 mmol/L) and low temperature (35°C) in the dialysate. the investigators will recommend urea reduction ratio \> 65% for each session.

Procedure: Intermittent hemodialysis (IHD)

CRRT group

EXPERIMENTAL

A central venous access (uncuffed nontunneled catheter, preferentially in the right jugular vein or femoral vein) and a biocompatible membrane will be used with a change of membrane every 72 hours (unless clotting occurs before). Choice between continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemofiltration (CVVHF), or continuous veno-venous hemodiafiltration (CVVHDF) will be left at physician discretion. The investigators will recommend a minimum delivered dose of dialysis of 20-25 ml/Kg/h of effluent by filtration and/or diffusion.

Procedure: continuous renal replacement therapy (CRRT)

Interventions

continuous renal replacement therapy (CRRT) PROCEDURE

renal replacement therapy (RRT).

CRRT group

Intermittent hemodialysis (IHD) PROCEDURE

renal replacement therapy (RRT).

IHD Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\> or= 18 years old) in ICU
• Receiving (or who have received) invasive mechanical ventilation and/or catecholamine infusion
• 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

You may not qualify if:

• Moribund state (patient likely to die within 24h)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

c 001 Avicenne Service de réanimation médico chirurgicale

Bobigny, 93000, France

RECRUITING

Related Publications (1)

• Gaudry S, Boubaya M, Louis G, Chaibi K, Megarbane B, Bohe J, Desgrouas M, Gele-Decaudin G, Joseph A, de Montmollin E, Camus C, De Prost N, Bailly P, Jaber S, Chudeau N, Lambour A, Robine A, La Combe B, Kimmoun A, Chevrel G, Argaud L, Nicolas J, Thiery G, Faguer S, Jozwiak M, Ricard JD, Contou D, Marzouk M, Chousterman B, Cadiet J, Bureau C, Zaleski ID, Rossignol P, Quenot JP, Queyrat CB, Dreyfuss D. Study protocol and statistical plan for the ICRAKI trial: Intermittent haemodialysis versus continuous renal replacement therapy for severe acute kidney injury in critically ill patients. Crit Care Resusc. 2025 May 6;27(2):100107. doi: 10.1016/j.ccrj.2025.100107. eCollection 2025 Jun.

  PMID: 40458742 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Stéphane GAUDRY

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Stéphane GAUDRY, Pr,MD, PhD

CONTACT

01.48.95.22.81; stephane.gaudry@aphp.fr

Didier DREYFUSS, Pr,MD, PhD

CONTACT

didier.dreyfuss@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 13, 2023
• Study Start: October 28, 2023
• Primary Completion: October 28, 2025
• Study Completion: January 28, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

FR (1)