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.: PACTR201911916675189 Date of Approval: 26/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intravenous Lipid Emulsion as an Adjuvant Therapy of Acute Clozapine Poisoning: A randomized Controlled Trial
Official scientific title Intravenous Lipid Emulsion as an Adjuvant Therapy of Acute Clozapine Poisoning: A randomized Controlled Trial
Brief summary describing the background and objectives of the trial The aim of this study is to assess the efficacy of intravenous lipid emulsion as an adjuvant therapy of acute clozapine poisoning. This aim based on previous usage of intravenous lipid emulsion as antidote in case of toxicity of multiple drugs.The ‘‘lipid sink’’ is the most widely known theory for explaining the action of ILEs in poisoning situation. They create intravascular bulk lipid phase that provides an alternative binding surface and therefore acts as a ‘‘sink’’ that effectively inactivates a fraction of the lipophilic drug molecules as antipsychotic drugs.
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 01/03/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 01/03/2020
Actual Last follow-up date 01/06/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group The standard supportive care plus SMOF Lipid infusion Initial bolus dose: 1.5 mL/kg over 1 to 2 minutes followed by maintenance dose (6 mL/kg) I.V infusion over one hour. After the infusion is completed the patient is continuously reassessed and the bolus dose can be repeated. Bolus dose over two minutes and maintenance dose over one hour. Period of hospital stay Intravenous lipid emulsions (ILEs) are used as a source of calories and essential fatty acids in patients who require parenteral nutrition. The standard supportive care included maintaining patent airways, oxygen administration, breathing support when neceassry, continous cardiac monitoring until all symptoms resolved and QTc interval returned to normal, treatment of hypotension by intravenous fluids. In addition, in all patients gastric decontamination was done by administration of a single dose activated charcoal (1gm/kg) by nasogastric tube. For patients with disturbed consciousness level and absent gag reflex, the airway was secured by cuffed endotracheal intubation before activated charcoal administration. 20
Control Group The standard supportive carof acute clozapine poisoning. The standard supportive care included maintaining patent airways, oxygen administration, breathing support when neceassry, continous cardiac monitoring until all symptoms resolved and QTc interval returned to normal, treatment of hypotension by intravenous fluids. In addition, in all patients gastric decontamination was done by administration of a single dose activated charcoal (1gm/kg) by nasogastric tube. For patients with disturbed consciousness level and absent gag reflex, the airway was secured by cuffed endotracheal intubation before activated charcoal administration. Period of hospital stay The standard supportive care included maintaining patent airways, oxygen administration, breathing support when neceassry, continous cardiac monitoring until all symptoms resolved and QTc interval returned to normal, treatment of hypotension by intravenous fluids. In addition, in all patients gastric decontamination was done by administration of a single dose activated charcoal (1gm/kg) by nasogastric tube. For patients with disturbed consciousness level and absent gag reflex, the airway was secured by cuffed endotracheal intubation before activated charcoal administration. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients (male or female) with moderate to severe acute clozapine poisoning according to poisoning severity score . 1. Asymptomatic and mild cases. 2. Pregnant and lactating women. 3. Patients with coingestion of other substances in addition to antipsychotics. 4. Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure). Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 80 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 27/04/2019 research ethics committee of Tanta Faculty of Medicine.
Ethics Committee Address
Street address City Postal code Country
elgesh street tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Intensive care unit (ICU) admission and/or mechanical ventilation,improvement in corrected QT interval, the duration of hospital stay, the total in hospital mortality. period of hospital stay
Primary Outcome improvement of consciousness measured by the Glasgow Coma Scale period of hospital stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta Poison Control Center elgesh street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sara mohsen elsayed abdlaziz basiouny hassan radwan street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sara mohsen elsayed basiouny hassan radwan tanta Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries heba lashin h.lashin@yahoo.com 00201020016903 hassan radwan tanta
City Postal code Country Position/Affiliation
tanta Egypt Lecturer of forensic medicine and Clinical Toxicology
Role Name Email Phone Street address
Principal Investigator sara mohsen drsaramohsen92@gmail.com 00201024344722 hassan radwan
City Postal code Country Position/Affiliation
tanta Egypt demonstrator of of Forensic Medicine and Clinical Toxicology
Role Name Email Phone Street address
Public Enquiries fatema elgazzar fm.elgazzar@gmail.com 00201004568919 elgesh
City Postal code Country Position/Affiliation
tanta Egypt Assistant Professor of Forensic Medicine and Clinical Toxicology Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes recorded data of patients in the trial Study Protocol 8 months All admitted patients (male or female) of any age, with moderate to severe acute clozapine poisoning according to poisoning severity score
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