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Væskebalance styret af modificeret venøs overflod ultralydsscanning versus standardpleje hos patienter med akut nyreskade, der modtager kontinuerlig renal erstatningsterapi (mVExUS-CRRT)

2. oktober 2026 opdateret af: Chulalongkorn University

Væskebalance styret af modificeret venøs excess ultralydsscanning versus standardbehandling hos patienter med akut nyreskade, der modtager kontinuerlig renal erstatningsterapi: Et multicentret randomiseret kontrolleret studie

The goal of this randomised controlled trial is to compare the cumulative fluid balance over the first 72 h following inclusion guided by mVExUS versus standard of care in critically ill patients with acute kidney injury receiving CRKT . It will also compare the proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care.

The main questions it aims to answer are:

Does fluid removal rate guided by mVExUS will reduce cumulative fluid balance over the course of the first 72 h of CRRT in ICU patients compared to standard care

Participants will:

Get fluid assessment by mVExUS protocol or a strandard care every 8 hours for 72 hours

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

After enrollment, the participants have to be randomized within 1 h. In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg >1000 mL/day.

This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strategy has to be restored.

The CRRT technique (haemodialysis, haemofiltration, haemodiafiltration) will be left at the discretion of the treating team. CRRT dose (i.e. dialysate or reinfusion fluids flow rate) will be prescribed at 25-30 ml/kg/hr according to the KDIGO guideline. CRRT dose and UFNET will be indexed to the patient's body weight, and in patients with a body mass index at 30 kg/m2, to the adjusted body weight (calculated as ideal body weight to which will be added 40% of the difference between the actual body weight and the ideal body weight - Du Bois formula). Choice of extra-corporeal circuit anticoagulation (heparin, citrate or none) and implantation site of CRRT catheters will be left at the discretion of the treating physician.

Vasopressors will be titrated as per unit-based protocols to maintain the mean arterial pressure within the bounds prescribed by the physician in charge (most frequently between 65 and 75 mmHg). Indications and category of vasopressors and inotropes will be left at the discretion of the treating team. The diuretic will be stopped once the patient is enrolled.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

126

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Thailand
      • Bangkok, Thailand, 10330
        • Rekruttering
        • King Chulalongkorn Memorial Hospital
        • Kontakt:
      • Bangkok, Thailand, 10300
        • Ikke rekrutterer endnu
        • Vajira Hospital, Navamindradhiraj University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults (≥ 18 years of age)
  • Admitted to ICU
  • Acute kidney injury by KDIGO criteria
  • Initiated CRRT by at least one of the following indications for RRT initiation:
  • Serum potassium ≥ 6.0 mmol/L, or
  • pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L, or
  • Evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload, or
  • Persistent severe AKI (sCr remains > 50% the value recorded at randomization) for > 72 hours from randomization
  • Participants giving informed consent

Exclusion Criteria:

  • Refuse to participate
  • Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy
  • Kidney transplant recipient
  • Receive RRT before ICU admission within 90 days
  • Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease
  • Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites.
  • Underlying disease process with a life expectancy less than 90 days
  • Pregnancy
  • Severe cardiac rhythm disturbances (tachyarrhythmia, supraventricular tachycardia)
  • Intra-cardiac shunts; Ventricle septal defect, patent foramen ovale, atrial septal defect
  • Aortic aneurysm
  • Intra-abdominal hypertension (intraabdominal pressure ≥20 mmHg)
  • Expected life expectancy <48 hours
  • Receiving extracorporeal membrane oxygenation (ECMO)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard pleje
Aktiv komparator: mVExUS-guidet væskebehandling
Procedure: mVExUS-guided fluid management

In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg >1000 mL/day.

This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
72-hour cumulative fluid balance between mVExUS-guided management and standard care in critically ill patients with acute kidney injury receiving CRKT.
Tidsramme: Hour 0, Hour 72

In the mVExUS-guided management the fluid removal rate will be guided based on mVExUS ultrasound results. In standard care the fluid removal rate is based on conventionval fluid assessment
Hour 0, Hour 72

Sekundære resultatmål

Resultatmål
Tidsramme
28- og 90-dages dødelighed mellem mVExUS-vejledt væskebehandling sammenlignet med standardbehandling
Tidsramme: 28 dage, 90 dage
28 dage, 90 dage
AKI-underfænotyper, kategoriseret efter angiopoietin-1, angiopoietin-2 og opløselig TNF-receptor-1, associeret med risiko for død hos kritisk syge patienter med akut nyreskade, der modtager CRRT
Tidsramme: 28 dage
28 dage
Andelen af CRRT-relaterede komplikationer - inklusive intradialytisk hypotension og arytmier - blandt patienter behandlet med mVExUS-styret væskebehandling og dem, der modtager standardbehandling
Tidsramme: Time 0, Time 72
Time 0, Time 72
Forskellige mønstre for væskeophobning og netto-ultrafiltreringsforløb samt sammenhæng med forskelle i 28-dages dødelighed hos kritisk syge patienter med akut nyreskade, der modtager CRRT
Tidsramme: 28 dage
28 dage

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chulalongkorn University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. september 2026

Primær færdiggørelse (Anslået)

1. marts 2029

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

24. december 2025

Først indsendt, der opfyldte QC-kriterier

7. januar 2026

Først opslået (Faktiske)

16. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0449/2568

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The datasets used and/or analysed will be available from the corresponding author on reasonable request.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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