Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05148611 |
Other study ID # |
ZS-3185D |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 30, 2021 |
Est. completion date |
October 1, 2025 |
Study information
Verified date |
September 2021 |
Source |
Peking Union Medical College Hospital |
Contact |
yi li, Medical PhD |
Phone |
15098750165 |
Email |
qmbb719[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
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 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.