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.: PACTR201811766698931 Date of Approval: 23/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Potential Role of Hydrocortisone in Acute Phosphide Poisoning: A Randamized Clinical Trial
Official scientific title The Potential Role of Hydrocortisone in Acute Phosphide Poisoning: A Randamized Clinical Trial
Brief summary describing the background and objectives of the trial The aim of this study was to evaluate the role of hydrocortisone as an adjuvant therapy in the management of patients with acute phosphide poisoning. This was a single blinded randomized clinical trial conducted on 30 patients with acute aluminium phosphide poisoning who were admitted to the Poison Control Unit in Emergency Hospital of Tanta University from the first of September 2016 to the end of September 2017. The current study was originally designed to include all phosphide poisoned patients admitted to the Poison Control Unit but during the study period, patients with zinc phosphide toxicity were presented with mild manifestations not consistent with the inclusion criteria of the current study. So, 30 Adult patients were randomly allocated into two equal groups (Group I and Group II) (15 patients in each group). Interventions included intravenous hydrocortisone (200mg/day) as an adjuvant to the standard treatment in Grroup I versus the standard treatment plus placebo(0.9% Sodium Chloride IV) in Group II . The standard treatment consists of patient resuscitation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.Outcome measures were assessed regarding mortality, need for mechanical ventilation , amount of vasopressors needed for normalization of blood pressure, arterial blood pressure at time of discharge and duration of hospital stay.
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 01/09/2016
Actual trial start date 01/09/2016
Anticipated date of last follow up 30/09/2017
Actual Last follow-up date 30/09/2017
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
31081/08/16
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hydrocortisone 200 mg /day intravenously until normalization of blood pressure and no need for vasopressors Hydrocortisone (SOLU-CORTEF) vial containing 100 mg of hydrocortisone sodium succinate powder with ampoule containing 2 ml of sterile water diluents in a dose of 200 mg /day intravenously. Hydrocortisone is short acting glucocorticoid preparation 15
Control Group Normal saline In the same manner as hydrocortisone The same as experimental group 0.9% Sodium Chloride Intravenous as placebo 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients with severe acute phosphide poisoning manifested by systolic blood pressure (SBP) ≤80 mmHg pH ≤7.2, or HCO3 ≤15 meq/L • Asymptomatic patients. • Patients ingested or exposed to other substances in addition to phosphide. • Patients with major medical conditions (e.g. cardiovascular disease, renal or hepatic failure). • Patients on steroids therapy. • Patients with medical interference by corticosteroid 24 hours before admission. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 53 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 01/08/2016 Research Ethics committe
Ethics Committee Address
Street address City Postal code Country
El- Geish Street, The medical campus Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality. At the time of patient discharge
Secondary Outcome • Need for mechanical ventilation. • Amount of vasopressors needed for normalization of blood pressure. • Arterial blood pressure at time of discharge. • Duration of hospital stay. No time point
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Poison Control Unit El- Geish Street, Emergency Hospital , Tanta University Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ghada Attia Sagah El- Geish Street, The medical campus Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University El- Geish Street, the medical campus Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Professor Mona Said Elgohary El- Geish Street, the medical campus Tanta 31527 Egypt
Professor Abdelmoty Mohamed Kabbash El- Geish Street, The medical campus Tanta 31527 Egypt
Dr Mona Mohamed Abo El Noor El- Geish Street, The medical campus Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ghada Sagah gh_attia@hotmail.com 00201003642188 El- Geish Street, The medical campus
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant lecturer of Forensic Medicine and Clinical Toxicology
Role Name Email Phone Street address
Public Enquiries Ghada Sagah gh_attia@hotmail.com 00201003642188 El- Geish Street, The medical campus
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Lecturer of Forensic Medicine and Clinical Toxicology
Role Name Email Phone Street address
Scientific Enquiries Mona Elgohary mona.elgouhari@med.tanta.edu.eg 00201222717667 El- Geish Street,The medical campus
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Forensic Medicine and Clinical Toxicology
Role Name Email Phone Street address
Scientific Enquiries Abdelmoty Kabbash abdelmotyk@yahoo.com 00201221218715 El- Geish Street,The medical campus
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Forensic Medicine and Clinical Toxicology
Role Name Email Phone Street address
Scientific Enquiries Mona Abo El Noor dr_moona2006@yahoo.com 00201024226088 El- Geish Street,The medical campus
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant Professor of Forensic Medicine and Clinical Toxicology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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