- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05148611
Application Registration Study of ILE in Patients With Acute Poisoning (ILE)
2. december 2021 opdateret af: Peking Union Medical College Hospital
In this study, the investigators aimed to study the effect of ILE in the treatment of acute fat-soluble substance poisoning,to further clarify the relevant mechanism of ILE in the treatment of fat-soluble drug poisoning,to standardize the relevant procedures of ILE detoxification treatment and further explore the adverse reactions and coping strategies of ILE treatment.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
Fat-soluble drugs refer to drugs that are insoluble in water but soluble in fats and organic solvents such as carbon tetrachloride, glycerol, oils and other organic solvents.
They can fuse with the phospholipid bilayer of cell membranes, are easily absorbed, and are easier to pass compared to water-soluble drugs.
It is metabolized by the liver, and the metabolites are excreted by the kidneys, so it has a high clinical use rate.
However, in recent years, due to the improper use of fat-soluble drugs by patients, fat-soluble benzodiazepines sedative and hypnotic drugs, fat-soluble calcium channel blockers and β-blocker drugs, fat-soluble tricyclic drugs have often occurred.
Poisoning such as antidepressants poses a serious threat to the lives of patients.In addition, organophosphorus pesticides (fat-soluble) have a high usage rate in China.
Severe organophosphorus poisoning can cause multiple organ damages, and delays in treatment can cause disability or even death.
Clinical treatment is mainly based on routine gastric lavage and oxygen inhalation.
Treatment is the mainstay, combined with medical drugs, hemodialysis, hemoperfusion, etc., and has achieved certain curative effects, but the mortality rate is still high, so it is of great significance to explore safer and more effective treatment methods.Intravenous lipid emulsion (ILE) was originally used to treat overdose of local anesthetics such as bupivacaine, and later also used to treat a variety of other lipophilic drug poisonings.
The research on the treatment of ILE is still in the preliminary stage and relatively limited.
A systematic review of fat emulsions for the treatment of acute poisoning found that the overall quality of the studies supporting this treatment is low or very low, but the included case reports indicate that fat emulsions are effective against verapamil, beta blockers, and certain Tricyclic antidepressants, bupivacaine, chlorpromazine, and certain antiarrhythmic drugs (eg, flecainide) poisoned patients have certain benefits.
ILE may help treat patients who are hemodynamically unstable due to poisoning by these drugs.In view of the fact that the research on the treatment of ILE still needs to be further improved and related adverse reactions need to be further explored related countermeasures, the investigators plan to launch a registration research program related to the application of fat emulsion.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
500
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: yi li, Medical PhD
- Telefonnummer: 15098750165
- E-mail: qmbb719@163.com
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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
N/A
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
According to the indications of ILE in the treatment of poisoning in clinical toxicology, the research objects are divided into the following categories:
- Calcium channel blocker poisoning
- Beta blocker drug poisoning
- Tricyclic antidepressant poisoning
- Organophosphorus (fat-soluble) pesticide poisoning, such as: chlorpyrifos, profenofos, diazinon, fenthion, phosphaphos, quinalphos, butylpyrimidin, thiazophos, omethoate, dimethoate Methionine, triazophos, thiomethionine, ethion, sulfoxiphos, imiphos, fosfoxcarb, pyrifoxaphos, hydrocarbophos, phorate, methyl parathion, parasulfur Phosphorus, dichlorvos, pyridoxine, etc.
- Local anesthetic poisoning
- Poisoning by other fat-soluble substances
Beskrivelse
Inclusion Criteria:
- Diagnosed as acute fat-soluble drug and organophosphorus (fat-soluble) pesticide poisoning;
- Conventional treatment is ineffective, especially for patients with circulatory failure, such as ventricular arrhythmia, shock, cardiac arrest, etc., who need intravenous fat emulsion treatment;
- Those who are not allergic to fat milk;
- Sign informed consent.
Exclusion Criteria:
- Mergers with insufficiency of important organs;
- Patients with malignant tumors;
- Severe mental disorder affects the treatment;
- Those with incomplete clinical data.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
mortality rate
Tidsramme: 24 hours
|
Patient mortality within 24 hours
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Circulatory system
Tidsramme: 24 hours
|
Circulation stabilization time: including blood pressure stabilization time, disappearance time of malignant arrhythmia, etc.
|
24 hours
|
|
mortality rate
Tidsramme: 1 week and 28 days
|
1 week and 28 days patient mortality
|
1 week and 28 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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 (Forventet)
30. november 2021
Primær færdiggørelse (Forventet)
30. december 2021
Studieafslutning (Forventet)
1. oktober 2025
Datoer for studieregistrering
Først indsendt
1. november 2021
Først indsendt, der opfyldte QC-kriterier
2. december 2021
Først opslået (Faktiske)
8. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. december 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ZS-3185D
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .