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Not yet recruiting NCT06966765

Accelerated vs Standard Approach to Continuous Veno-venous Hemodiafiltration Post-hemoperfusion (ASAP) in Severe Acute Diquat Poisoning

Phase III Interventional Diquat Poisoning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous Veno-Venous Hemodiafiltration.
Who it may be relevant to
Registry conditions: Diquat Poisoning. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Accelerated vs Standard Approach to Continuous Veno-venous Hemodiafiltration Post-hemoperfusion (ASAP) in Severe Acute Diquat Poisoning: a Multi-center, Cluster, Randomized, Controlled Trial

Overview

Diquat (1,1'-ethylene-2,2'-bipyridinium) is a bipyridine herbicide that shares a similar physicochemical structure and redox cycling mechanism with paraquat. Upon ingestion, it is rapidly absorbed and distributed to the gastrointestinal tract, kidneys, liver, skeletal muscle, lungs, myocardium, and central nervous system. Patients with severe diquat poisoning often develop toxic encephalopathy, circulatory collapse, and multi-organ dysfunction. Extracorporeal treatments, including hemoperfusion, hemodialysis, and continuous kidney replacement therapy (CKRT), are widely employed to manage diquat poisoning. Continuous veno-venous hemodiafiltration (CVVHDF), the most frequently used CKRT modality, is primarily indicated for acute kidney injury (AKI). AKI occurs in up to 73.3% of patients with acute diquat poisoning, and nearly all patients with severe acute diquat poisoning are at risk of developing AKI. In clinical practice, patients with severe acute diquat poisoning are typically defined as those with a plasma diquat concentration of ≥1000 ng/mL measured at the time of presentation to the emergency department (ED). However, the Extracorporeal Treatments in Poisoning (EXTRIP) workgroup has not issued any definitive recommendations on initiating extracorporeal treatments for diquat poisoning, and the optimal timing for starting CVVHDF has yet to be evaluated in clinical trials. Currently, the standard practice delays initiation of CVVHDF until AKI has developed. Accordingly, this study proposes a pragmatic cluster-randomized controlled trial (RCT) to determine whether, in severe acute diquat poisoning patients, accelerated initiation of CVVHDF following hemoperfusion is preferred compared to a standard approach in which CVVHDF is initiated only in the presence of AKI or at the discretion of the treating clinician.

Interventions

  • Procedure Continuous Veno-Venous Hemodiafiltration
    CVVHDF will be delivered following hemoperfusion with a dialysate-to-replacement fluid ratio maintained at 1:1, a blood flow rate of 150-200 mL/min, and a target dialysis dose of 30 mL/kg/h (excluding additional fluid removal). Regional anticoagulation (e.g., heparin or other agent per device requirements) will be used to prevent clotting within the circuit. Once CVVHDF is initiated in either arm, it will not be discontinued until one of the following encountered: (i) death; or (ii) a change in

Primary outcome measures

  • All-cause mortality rate [Time frame: 90 days within the index date of randomization]
  • Time from exposure to death [Time frame: 90 days within the index date of randomization]
Secondary outcome measures (6)
  • ICU-free days [Time frame: 90 days within the index date of randomization]
  • Ventilator-free days [Time frame: 90 days within the index date of randomization]
  • Vasoactive-free days [Time frame: 90 days within the index date of randomization]
  • CVVHDF dependence rate [Time frame: 90 days within the index date of randomization]
  • Hospitalization-free days [Time frame: 90 days within the index date of randomization]
  • Major adverse kidney events rate [Time frame: 90 days within the index date of randomization]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years; and
  • A history of oral exposure to diquat solution, reported by patient(s) or their legal proxies; and
  • An exposure time (time form exposure to presentation at ED) ≤ 48 hours, reported by patient(s) or their legal proxies; and
  • Plasma diquat concentration measured upon ED presentation ≥ 1,000 ng/mL.

Exclusion criteria

  • Evidence of co-ingestion of other toxic substances alongside diquat; and/or
  • Withholding of CVVHDF due to limitations on the escalation of life-sustaining therapies; and/or
  • Any CKRT within the previous 2 months; and/or
  • Kidney transplant within the past 365 days; and/or
  • Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate calculated using serum creatine (eGFRer) of less than 30 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, if pre-hospitalization serum creatine is available; and/or (6) Treating clinician(s) believe(s) that either immediate or deferral of CVVHDF initiation is mandated; and/or (7) Pregnant or breast feeding.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06966765 · 2025-12122-2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗