Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05148611
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-12-08
First Post:
2021-11-01
Brief Title:
Application Registration Study of ILE in Patients With Acute Poisoning
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Application Registration Study of ILE in Patients With Acute Poisoning
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILE
Brief Summary:
In this study the investigators aimed to study the effect of ILE in the treatment of acute fat-soluble substance poisoningto further clarify the relevant mechanism of ILE in the treatment of fat-soluble drug poisoningto standardize the relevant procedures of ILE detoxification treatment and further explore the adverse reactions and coping strategies of ILE treatment
Detailed Description:
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 patientsIn 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 methodsIntravenous 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 drugsIn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None