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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102767216677 Date of Approval: 11/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Possible Therapeutic Role of Intravenous Lipid Emulsion in Acute Aluminium Phosphide Poisoning: A Randomized Controlled Clinical Trial
Official scientific title The Possible Therapeutic Role of Intravenous Lipid Emulsion in Acute Aluminium Phosphide Poisoning: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Intravenous lipid emulsion (ILE) therapy is a novel treatment that is being used to reverse the acute toxicity of some xenobiotic with varied success. It has been used as antidote for cardiovascular and central nervous system sequelae of local-anaesthetic systemic toxicity. Additionally, lipid emulsion therapy has been successfully used in cardiovascular resuscitationThe aim of this study is to assess the biochemical and clinical efficacy and safety of intravenous lipid emulsion as an adjuvant therapy in acute aluminium phosphide poisoning.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/07/2020
Actual trial start date 15/07/2020
Anticipated date of last follow up 01/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 62
Recruitment status Recruiting
Publication URL Not published yet
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous Lipid Emulsion bolus dose of 1.5 ml/kg over 1 min followed by continuous IV infusion of 0.25 ml/kg/min, which should be continuously infused for at least 10 min after hemodynamic stability is obtained. If hemodynamic stability is not obtained, bolus dose could be repeated 1-2 times followed by doubled infusion rate (0.5 ml/kg/min) as continuous IV infusion. The recommended upper limit is 10 ml/kg over the first 30 minutes bolus dose of 1.5 ml/kg over 1 min followed by continuous IV infusion of 0.25 ml/kg/min, which should be continuously infused for at least 10 min after hemodynamic stability is obtained. If hemodynamic stability is not obtained, bolus dose could be repeated 1-2 times followed by doubled infusion rate (0.5 ml/kg/min) as continuous IV infusion. The recommended upper limit is 10 ml/kg over the first 30 minutes Experimental group : Intravenous lipid emulsion 20% will be given as bolus dose of 1.5 ml/kg over 1 min followed by continuous IV infusion of 0.25 ml/kg/min, which should be continuously infused for at least 10 min after hemodynamic stability is obtained. If hemodynamic stability is not obtained, bolus dose could be repeated 1-2 times followed by doubled infusion rate (0.5 ml/kg/min) as continuous IV infusion. The recommended upper limit is 10 ml/kg over the first 30 minutes Control group : The standard treatment only will be administered to the patients allocated in this group 31
Control Group The standard treatment of aluminum phosphide Intoxication according to Tanta university poison treat the standard ALP treatment according to TUPTC protocol of treatment was provided as follows: Patient resuscitation including care of airway, breathing and circulation. Intravenous fluids and vasopressors (Norepinephrine) will be used to treat hypotension and refractory shock (Baeeri et al., 2013). Decontamination: Patients presented within 2 hours of ALP ingestion will be subjected to gastric lavage using normal saline mixed with sodium bicarbonate solution (2 ampoules sodium bicarbonate 25% added to each 500cc saline), followed by a single (50 mg) dose of activated charcoal. For metabolic acidosis, intravenous sodium bicarbonate will be considered. Magnesium sulfate: 1g IV infusion every 1hour for the first 3 hours, followed by 1–1.5 g every 6 hours for 24 hours (Gurjar et al., 2011) the standard ALP treatment according to TUPTC protocol of treatment was provided as follows: Patient resuscitation including care of airway, breathing and circulation. Intravenous fluids and vasopressors (Norepinephrine) will be used to treat hypotension and refractory shock (Baeeri et al., 2013). Decontamination: Patients presented within 2 hours of ALP ingestion will be subjected to gastric lavage using normal saline mixed with sodium bicarbonate solution (2 ampoules sodium bicarbonate 25% added to each 500cc saline), followed by a single (50 mg) dose of activated charcoal. For metabolic acidosis, intravenous sodium bicarbonate will be considered. Magnesium sulfate: 1g IV infusion every 1hour for the first 3 hours, followed by 1–1.5 g every 6 hours for 24 hours (Gurjar et al., 2011) the standard ALP treatment according to TUPTC protocol of treatment was provided as follows: Patient resuscitation including care of airway, breathing and circulation. Intravenous fluids and vasopressors (Norepinephrine) will be used to treat hypotension and refractory shock (Baeeri et al., 2013). Decontamination: Patients presented within 2 hours of ALP ingestion will be subjected to gastric lavage using normal saline mixed with sodium bicarbonate solution (2 ampoules sodium bicarbonate 25% added to each 500cc saline), followed by a single (50 mg) dose of activated charcoal. For metabolic acidosis, intravenous sodium bicarbonate will be considered. Magnesium sulfate: 1g IV infusion every 1hour for the first 3 hours, followed by 1–1.5 g every 6 hours for 24 hours (Gurjar et al., 2011) 31 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged ≥ 12 years old. Either gender male or female. Symptomatic acute ALP poisoning. Diagnosis will be made on the basis of: 1. The suggestive clinical manifestations due to and following shortly after exposure to ALP. 2. Reliable identification of the compound based on the container brought by patient attendants 3. Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test) Patients less than 12 years old. Pregnant and lactating women. Patients with mixed ingestion or exposure. Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure). Patients treated for acute phosphide poisoning in any medical center before admission. Patient with hyperlipidemia (serum triglyceride levels exceeds 400 mg/dL) 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 100 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 15/06/2020 Tanta University ethical committee
Ethics Committee Address
Street address City Postal code Country
ElGeish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality Mortality
Secondary Outcome Mean arterial blood pressure Need for intubation. Need for mechanical ventilation. The total dose of vasopressor needed. Duration of hospital stay. Serum lactate levels. Mean arterial blood pressure Need for intubation. Need for mechanical ventilation. The total dose of vasopressor needed. Duration of hospital stay. Serum lactate levels.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Poison Treating Centre El Geish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hafsa Salah Mostafa Gheat El Geish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hafsa Salah Gheat ElGeish street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Manar Maher Fayed Saeed street Tanta 31527 Egypt
Fatma Mohamed El gazzar El Geish Street Tanta 31527 Egypt
Iman Ibrah Draz Saeed street Tanta 31527 Egypt
Rabab Sayed Ahmad Elkelany Hassan Radwan street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hafsa Gheat hafsasalah66@gmail.com +2001123558563 ElGeish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Fatima El Gazzar fm.elgazzar@gmail.com +201123558563 El Geish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Manar Maher Manarmaher85@gmail.com +201123558563 El Geish street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Study Protocol one year all ALP poisoned patient above 12 years old of both sexes admitted to tanta university hospital poison control center within 6 hours of ingestion
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