Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202408492665945 Date of Registration: 13/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Adjuvant Role of Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Patients
Official scientific title The Adjuvant Role of Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Patients
Brief summary describing the background and objectives of the trial This trial aims to evaluate the efficacy and safety of adding sevelamer in the treatment of acute aluminum phosphide poisoned patients admitted to Tanta University Poison Control Center. Aluminum phosphide poisoning is an increasing global health problem accounting for 40-80% of the incidence of pesticide poisoning worldwide. It is considered to be a common method of suicide in most developing countries such as North India, Iran and Egypt. Moreover, the observational study carried out in the Middle Delta of Egypt showed that the incidence of ALP poisoning was more than 25% of all poisoning cases. Moreover, aluminum phosphide is a cheap, widely used and effective solid fumigant often used for grain preservation. Aluminum phosphide is marketed as a dark grey tablet with multiple brand names.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acute aluminum phosphide toxicity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2024
Actual trial start date 18/07/2024
Anticipated date of last follow up 31/05/2026
Actual Last follow-up date 31/05/2026
Anticipated target sample size (number of participants) 135
Actual target sample size (number of participants) 135
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group I All patients (45 patients) will be managed according to the treatment protocol of aluminum phosphide (ALP) toxicity in Tanta University Poison Control Center (TUPCC);  Emergency measures for airway, breathing and circulation.  Dry gastric aspiration of contents with naso-gastric tube then giving 4-5 bottles (250 ml) of paraffin oil and leave the oil in place.  Symptomatic and supportive treatments including: · Treatment of hypo-tension or shock (intravenous fluid and vasopressors). · Treatment of acidosis (full correction by sodium bicarbonate). All patient will treated according to this protocol along time of acute toxicity within the duration of study (2 years) All patients (45 patients) will be managed according to the treatment protocol of ALP toxicity in TUPCC;  Emergency measures for airway, breathing and circulation.  Dry gastric aspiration of contents with naso-gastric tube then giving 4-5 bottles (250ml) of paraffin oil and leave the oil in place.  Symptomatic and supportive treatments including: · Treatment of hypotension or shock (intravenous fluid and vasopressors). · Treatment of acidosis (full correction by sodium bicarbonate). 45 Active-Treatment of Control Group
Experimental Group Group IIa Patients will take sevelamer carbonate; Two tablets (800 mg) orally as a whole or suspended in oil within 2 hours of acute poisoning (total 1.6 g/day). Once 2 tabs of sevelamer carbonate (800 mg) within 2 hours of acute poisoning (total 1.6 g/day). - All patients will receive the standard treatment as the control group in addition to sevelamer carbonate 800 mg tablets. - Patients will take sevelamer carbonate; two tablets (800 mg) orally as a whole or suspended in oil within 2 hours of acute poisoning (total 1.6 g/day) parallel with other symptomatic treatment according to protocol of Ta 45
Experimental Group Group IIb Patients will take sevelamer carbonate; four tablets (800 mg) orally as a whole or suspended in oil within 2 hours of acute poisoning (total 3.2 g/day) Once four tablets (800 mg) orally as a whole or suspended in oil within 2 hours of acute poisoning (total 3.2 g/day) - All patients will receive the standard treatment as the control group in addition to sevelamer carbonate 800 mg tablets. - Patients will take sevelamer carbonate; four tablets (800 mg) orally as a whole or suspended in oil within 2 hours of acute poisoning (total 3.2 g/day). 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
➢ All symptomatic acute ALP poisoned patients aged 12 years or older (male and female). ➢ Patients admitted within 2 hours of exposure. Diagnosis will be based on the following: - History of exposure from the patient and or his/her relatives, -Availability of tablets container brought by the patient’s relatives, -Suggestive clinical manifestations (symptoms and signs). ➢ Patients aged less than 12 years old. ➢ Delayed time of presentation more than 2 hours. ➢ Patients with history of chronic comorbidities like cardiovascular disease, chronic kidney disease, chronic liver disease, diabetes and chronic pulmonary disease. ➢ Patients with mixed ingestion. ➢ Patients received any medical intervention before admission. ➢ Pregnant and lactating women. ➢ Patients with known hypersensitivity to sevelamer or any of its constituents. ➢ Patients who have bowel obstruction, active dysphagia, swallowing disorder, ileus, or severe gastrointestinal motility disorders including severe constipation, fecal impaction and bowel perforation. ➢ Patients who are using anti-arrhythmic or anti-seizure medications 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2024 Faculty of Medicine Research Ethical Committee Tanta University
Ethics Committee Address
Street address City Postal code Country
Gharbia Governorate, Tanta City, El-Gish St., Medical Complex, Faculty of Medicine Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality rate. post intervention
Secondary Outcome Need for intubation or intensive care unit admission. during intervention
Secondary Outcome Duration of hospital stay. during the intervention
Secondary Outcome Total dose of vasopressors. during the intervention
Secondary Outcome Arterial blood pressure. pre intervention and during the intervention
Secondary Outcome Arterial blood gas parameters. pre intervention and during the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Poison Control Center Gharbia Governorate, Tanta City, El-Gish St., Medical Complex, Faculty of Medicine Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Me Egypt, Gharbia Governorate, Tanta, Ali bin Abi Talib Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University Hospital Gharbia Governorate, Tanta, EL- Ghaish Street Tanta 31527 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Asmaa Gamal Salah asmaa.gamal93@med.tanta.edu.eg 01094691133 Egypt, Gharbia Governorate, Tanta, Ali bin Abi Talib Street
City Postal code Country Position/Affiliation
Tanta 31535 Egypt Assistant Lecturer of Forensic Medicine and Clinical Toxicology Department Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Ghada Attia sagah Sagah ghadaattia@med.tanta.edu.eg 01003642188 Al-Rifai Street, from the end of Al-Bahr Street - Tanta - Gharbia
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of Forensic Medicine and Clinical Toxicology Tanta University
Role Name Email Phone Street address
Principal Investigator Khaled Mahmoud Saad khaled.Saad@med.tanta.edu.eg 01028084041 Sheikh Issa Al-Azaby St., Kafr El-Zayat, Gharbia
City Postal code Country Position/Affiliation
Tanta 31611 Egypt Professor of Clinical Toxicology Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication. Study Protocol From 12 to 36 months after article publication. Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information