Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06032884

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-05

1000

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years old or older in intensive care unit
  • Receiving or have received invasive mechanical ventilation and/or catecholamine infusion
  • Availability of both intermittent hemodialysis and continuous renal replacement therapy equipment at the center
  • Have either persistent severe hyperkalaemia despite medical treatment, persistent severe metabolic acidosis despite medical treatment, or severe pulmonary edema due to fluid overload despite diuretic therapy
  • Or have KDIGO stage 3 acute kidney injury with serum urea concentration over 40 mmol/L or oligo-anuria lasting more than 3 days
  • Affiliated with a social security system
  • Written consent obtained from patient or authorized representative, or inclusion without initial consent in emergencies if patient cannot consent and no representative is available
Not Eligible

You will not qualify if you...

  • Moribund state with expected death within 24 hours
  • Previous inclusion in this study
  • Under legal protection or deprived of freedom (e.g., guardianship or curatorship)
  • Receiving state medical aid
  • Pregnant or breastfeeding women
  • Currently participating in another acute kidney injury research trial
  • Advanced chronic kidney disease with estimated glomerular filtration rate below 20 mL/min/1.73 m2
  • Presence of drug overdose or dialyzable toxin requiring renal replacement therapy
  • Presence or suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy, or acute interstitial nephritis
  • Brain injury or other causes of increased intracranial pressure
  • Fulminant hepatic failure

AI-Screening

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Trial Site Locations

Total: 1 location

1

c 001 Avicenne Service de réanimation médico chirurgicale

Bobigny, France, 93000

Actively Recruiting

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Research Team

S

Stéphane GAUDRY, Pr,MD, PhD

CONTACT

D

Didier DREYFUSS, Pr,MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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