Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06111352 |
| Other study ID # |
59.18.1100.031.18.011.22.2268 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
November 2023 |
| Est. completion date |
October 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Sir Salimullah Medical College Mitford Hospital |
| Contact |
Prof. Dr. Ahmed Hossain, FCPS |
| Phone |
+8801711238612 |
| Email |
ahmedhossain31[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This open level randomized controlled trial will be conducted in the department of medicine
at Sir Salimullah Medical College and Mitford Hospital. Clinical severity will be assessed by
the POP (Peradeniya Organophosphorus Poisoning) scale of admitted patients having a history
of organophosphorus poisoning within 24 hours with clinical features and physical evidence of
poisoning consumed. Only moderate severity (POP Scale score 4-7) of OPC (Organophosphorus
compound) patients will be included in this study. Then one group of patients will be treated
with atropine and pralidoxime and another group will be treated with atropine. The outcome
will be noted as clinical improvement or recovery. hospital stay, requirement of ICU, death.
Description:
OPC poisoning is one of the most medical emergencies manage in hospital in our country. For
the treatment of this acute cases, along with the supportive measures, intravenous
anticholinergic atropine is the mostly used antidote. WHO (World Health Organization)
recommended the use of intravenous pralidoxime along with atropine for favorable outcomes,
while several studies had doubted effectiveness of its use for the treatment of OPC
poisoning. Therefore, the aim of this study is assessment of the outcomes of patients with
OPC poisoning of moderate severity between two treatment groups one will be treated with
atropine plus Pralidoxime and other with only atropine. This open level randomized controlled
trail will be conducted in department of Medicine, Sir Salimullah Medical College & Mitford
Hospital, Dhaka. All the patient admitted in the hospital during the study period with OPC
poisoning will be evaluated by clinical presentation. Form the total patients, those patients
with the history of organophosphorus poisoning within previous 24 hours with clinical
features of poison consumption with moderate severity after assessing by Peradeniya OP (POP)
Scale and considering the inclusion and exclusion criteria; participant/patients will be
enrolled in the study. A total 96 patients will be enrolled in the study. After inclusion in
the study the participant will be randomly allocated following simple randomization technique
in both treatment group [atropine plus pralidoxime group (Group A) and atropine only group
(Group B). The nature of the chemical composition of the organophosphorus compound will be
identified from the brought sample.
The patients of group (A) will be treated with atropine plus pralidoxime and all the patients
of group (B) will be treated with atropine only. All patients will receive other supportive
therapy with stomach wash, i.v. fluid, antibiotics, and O2 inhalation as required. Every
patient will be followed up by careful clinical examination. Patients developing respiratory
failure will be identified by clinical examination and by using pulse oximetry. These
Patients will be treated in ICU of Sir Salimullah Medical College & Mitford Hospital and
assisted ventilation support will be given. Both groups will be further analyzed from the
start of poisoning to arrival at hospital and up to recovery/ ICU support/Death.
Each ampoule of inj atropine contained 0.6 mg atropine sulphate and each vial of inj.
pralidoxime contained pralidoxime 1gm. Both drugs will be used in iv route. Inj. pralidoxime
will be given as intravenous infusion over 4 minutes to avoid hypotension. Both antidotes
will be administered as per recommended dosage schedule.
Inj. Atropine (3 ampule) will be given in intravenous route as a first dose, rapidly. Then
the dose will be doubled from the previous dose in every 5 minutes interval until the signs
of atropinisation appeared. Then infusion of 10% of the total bolus dose (the dose that was
given until the signs of atropinisation appeared) per hour, will be given with intravenous
Normal saline/ 5% DNS(Dextrose and Sodium chloride infusion) as a maintenance dose. The dose
will be reduced for adjustment, based on clinical features/improvement. Inj. Pralidoxime 1 gm
I/V will be given as first dose over 10-20 minutes. If no improvement of muscle weakness,
then repeat the dose after one hour. Then 1 gram of Inj. Pralidoxime will be given at an
8-hour interval. The atropine and pralidoxime dose will be continued until symptomatic
improvement and recovery. After discontinue of antidote further patient will be observed
24-48 hours then patient will be discharge. Study outcomes will provide any benefit of
pralidoxime in moderately severe OPC poisoning patients.
