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.: PACTR202009754904918 Date of Approval: 16/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hemoperfusion for organophosphate poisoning in critically ill patients- A randomized trial.
Official scientific title Hemoperfusion for organophosphate poisoning in critically ill patients- A randomized trial.
Brief summary describing the background and objectives of the trial Organophosphate poisoning (OPP) is a significant local and global health concern. WHO reports around 3 million cases/year of pesticide poisoning – predominantly OPP. South Africa’s burden from OPP is comparable with other developing countries. Locally our incidence has been steadily increasing with approximately 2 admissions/month in 2017. Organophosphates contain carbon and phosphorus derivatives that are well absorbed through the lungs, the gastrointestinal tract and skin. They then bind to acetylcholinesterase both in the red cell and in the serum. This leads to uninhibited, prolonged activity of acetylcholine (Ach) at the synaptic and neuromuscular junctions. Current recognized treatment includes atropine and oximes. However, despite early atropinization length of stay in ICU is protracted and leads to numerous complications. Novel treatment strategies such as hemodialysis and hemoperfusion show promise from various earlier and recent trials. Our research Questions is: Will the early application of a hemoperfusion cartridge reduce the toxin load and change the clinical course of the disease to a milder one requiring less resources and with fewer complications? The specific objectives of the study are: Primary: To determine if hemoperfusion results in a shorter length of ICU stay (LOS ICU) Secondary: To determine the following differences between the 2 groups: Cost of ICU stay Duration of antidote Cumulative antidote dose Duration of mechanical ventilation Vasopressor days Motor score (max 60) at D5 or ICU discharge if pre D5 Other complications (composite of various complications – see methods) ICU Mortality D28/Hospital discharge mortality Serum organophosphate (OP) and carbamate (Cb) levels will be compared at the following time points: D0 peak (pre hemoperfusion), D0 trough (post hemoperfusion), D1 peak, D1 trough, D2 concentration Serum cholinesterase and red cell cholinesterase on D0 and ICU discharge
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: Devices
Anticipated trial start date 06/01/2020
Actual trial start date
Anticipated date of last follow up 03/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Haemoperfusion How Much: Blood Flow = 150-200ml/min Feqeuncy: once per 24hour cycle x2 (on Day 0 and Day 1) 6 hours Haemoperfusion filter Specific for Organophosphate removal 20
Control Group Standard care not applicable Standard Care using medication to limit effects of toxins 20 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult patients admitted to the ICU with a diagnosis of organophosphate poisoning will be included. Age ≥18 years Consistent History Cholinergic toxidrome Patient recruitment within 12 hours of ICU admission Written informed consent Patients with polypharmacy overdoses were excluded Patients with a contra-indication to anticoagulation with heparin and enoxaparin 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 08/11/2019 Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace, Parktown, Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ICU length of Stay ICU Discharge
Secondary Outcome Mortality ICU Discharge/Hospital Discharge/Day 28
Secondary Outcome Serum Organophosphate and Carbamate levels Admission day pre and post haemoperfusion, day 1 pre and post haemoperfusion and day 2
Secondary Outcome Cost of ICU stay ICU discharge
Secondary Outcome Duration and Dose of antidote ICU Dsicharge
Secondary Outcome Duration of Organ support ICU Discharge
Secondary Outcome Motor Score Day 5 or ICU Discharge If prior to D5
Secondary Outcome Complications ICU Discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital 26 Chris Hani Road Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Shahed Omar 26 Chris Hani Road, Soweto Johannesburg 1864 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jalo Unit 17A, Knightsgate Industrial Park 1 Jonas Road Germiston West 1401 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shahed Omar shahedicu@gmail.com +27835695363 26 Chris Hani Road, Soweto
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa Intensivist
Role Name Email Phone Street address
Public Enquiries Ayesha Khan Ayesha.Khan@wits.ac.za +27825503102 26 Chris Hani Road, Soweto
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa Paediatric Intensivist
Role Name Email Phone Street address
Scientific Enquiries Shahed Omar shahed.omar@wits.ac.za +27835695363 26 Chris Hani Road
City Postal code Country Position/Affiliation
Soweto 1864 South Africa Senior Specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Clinical Study Report Within 12 months from study completion Controlled by principal investigator (PI). Anonymous data will be considered for access after PI and study team have ensured ethical clearance for requested sharing.
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