Aluminium Phosphide PoisoningAlPNCT05334667
CRRT Versus Plasmapheresis in Aluminum Phosphide Poisoning
A study testing Routine management, CRRT and PPH in people with Aluminium Phosphide Poisoning, run by Assiut University.
Trial summary
Aluminum phosphide (AlP) is a solid fumigant pesticide sold as tablets in use since the 1940s. It is considered to be an ideal pesticide because of its cheapness, efficiency, and easy availability in the market and is widely used as a grain preservative worldwide.The mortality in cases of aluminum phosphide poisoning… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aluminium Phosphide Poisoning
- What is being tested?
- Routine management, CRRT and PPH
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients exposed to AlP poisoning of either sex.
- Critically ill with severe symptomatic acute AlP poisoning; SBP<90mmHg, PH<7.32 and HR<60 bpm.
- Age >18 year.
Who cannot join
- Refusal to consent participating research.
- Age <18 years.
About this study
Official title: Comparison Between the Effect of Continuous Renal Replacement Therapy Versus Plasmapheresis on Mortality Rate in Aluminum Phosphide Poisoning; Randomized Controlled Study
Aluminum phosphide (AlP) is a solid fumigant pesticide sold as tablets in use since the 1940s. It is considered to be an ideal pesticide because of its cheapness, efficiency, and easy availability in the market and is widely used as a grain preservative worldwide.The mortality in cases of aluminum phosphide poisoning varies between 60% and 90%, even in experienced and well-equipped hospitals. Patients mostly die due to cardiovascular collapse, refractory shock, severe acidemia, fulminant hepatic failure, and or adult respiratory distress syndrome.
Continuous renal replacement therapy (CRRT) is a slow and smooth continuous extracorporeal blood purification, which is designed to replicate depurative function of the kidney. It is usually implemented over 24 h to several days with an aim of gentle correction of fluid overload and removal of excess uremic toxins. Furthermore, many observational studies considered CRRT as the predominant form of RRT in the intensive care unit (ICU) for critically ill patients with AKI and/or multiorgan failure, along with acute brain injury or other causes of increased intracranial pressure or generalized brain edema. The effectiveness of CRRT is mainly due to its accurate volume control, steady acid-base and electrolyte correction, and achievement of hemodynamic stability in adults and pediatrics.
Plasmapheresis (PPH) can rapidly and effectively remove toxic substances and their potentially toxic metabolites from the blood compartment, especially those with high protein-binding. As the potential benefit of therapeutic plasma exchange is increasingly recognized, its use is becoming more widespread, and case reports have confirmed its value in the treatment of drug overdose. The application of plasmapheresis dramatically reversed the severe biochemical and clinical manifestations and was able to prevent serious co-occurrence.
Read the detailed description
Seventy five (75) patients will be included in this study. They will be randomly allocated into three groups (25 patients | each)
- Control Group (C Group): routine management.
- CRRT Group: routine management + CRRT.
- PPH Group: routine management + PPH.
Immediately after ICU admission:
All Patients will receive the routine management including:
- Care for airway, breathing and circulation.
- Intravenous fluids guided by central venous pressure measurement and vasopressors (Norepinephrine) IV infusion will be used to treat hypotension and refractory shock, intubation and mechanical ventilation in the following conditions: apnea, respiratory failure, hypoxia, inadequate ventilation, disruption of airway reflexes, disturbed conscious level (GCS <8).
- Phosphine excretion can be increased by maintaining adequate hydration and renal perfusion with intravenous fluids and low dose dopamine (4-6 μg/kg/min). Diuretics like furosemide can be given if systolic blood pressure is >90 mm Hg to enhance excretion as the main route of elimination of phosphine is renal.
- Correction of metabolic acidosis by intravenous sodium bicarbonate will also be considered in a dose of 50-100 mEq intravenously every 8 hour till the bicarbonate level rises to 18-20 mEq/L.
- Additionally, magnesium sulfate: 1g IV infusion every 1hr for the first 3 hrs, followed by 1-1.5 g every 6 hrs for 24 hrs was administered.
- Decontamination will be done by gastric lavage using normal saline mixed with sodium bicarbonate solution (2 ampoules sodium bicarbonate 25% added to each 500cc saline) in all Patients presented within 2 hrs of toxic ingestion. Then, a single (50 gm) dose of activated charcoal will be administered.
Then patients will receive either CRRT or PPH after confirmation of exposure to aluminum phosphide.
Peri-interventional evaluation: -
- Time elapsed between exposure and start of management.
- Standard vital signs (ABP, HR, Spo2, ETCO2). ECG and GCS are continuously monitored and documented.
- Laboratory studies:
- Phosphine gas level in blood by gas chromatography: on admission and another sample after CRRT or PPH
- Tropnin levels immediately on admission and at the end of CRRT or PPH.
- ABG to assess acid base status and lactate levels. Basic sample on admission and serial samples every 2 hours after the start of CRRT or PPH for follow up, evaluation and assessment.
Prisma-flex (Gambro-Swedan) machine will be used to carry out both CRRT and PPH sessions. Each CRRT session continue for 72 hours, while PPH session continue for 4 hours. The need for another session will be evaluated by the SBP< 90 mmHg, lactate level >1mmol, acid base status; PH<7.35 and renal function; S. creatinine>2.
All participating patients will be observed until discharge from the hospital or death. Continuous monitoring and documentation of their vital signs, oxygen saturation, and conscious level will be done.
Parameters to be evaluated regularly
- Laboratory studies
- CBC, Coagulation profile (PT, PC, INR) if within normal, reassessment after 48 hours.
- Liver function tests LFTs if within normal, reassessment after 48 hours.
- Urea and creatinine will be assessed daily.
- Troponin T and I if within normal, reassessment after 48 hours.
- Blood glucose/ 4 hours for the first 48 hours then every 8 hours.
- K, Mg, Ca will be assessed daily.
- Standard monitoring: ABP, HR, Spo2, ETCO2 and ECG continuously.
- 24 hours total urine output (UOP).
- Conditions
- Aluminium Phosphide Poisoning
- Being tested
- Routine management, CRRT, PPH
- Keywords
- CRRT, Plasmapheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine managementOther
Routine management
CRRTDevice
Prisma-flex (Gambro-Swedan) machine will be used to carry out both CRRT and PPH sessions. Each CRRT session continue for 72 hours, while PPH session continue for 4 hours.
PPHDevice
Prisma-flex (Gambro-Swedan) machine will be used to carry out both CRRT and PPH sessions. Each CRRT session continue for 72 hours, while PPH session continue for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients will receive routine management only. Receives: Other: Routine management |
| CRRT group | Active comparator | Patients will receive CRRT and routine management. Receives: Other: Routine management; Device: CRRT |
| PPH group | Active comparator | Patients will receive plasmapheresis and routine management. Receives: Other: Routine management; Device: PPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Evaluation of the effect of CRRT versus PPH on mortality rate in acute AlP poisoning, (30 days mortality).
Measured: 30 days
Secondary outcomes (4)
ICU
ICU stay.
Measured: 30 days
Morbidity
Thirty days morbidity: organ dysfunction secondary to poisoning (e.g. renal failure, pancreatitis, DM).
Measured: 30 days
Sessions
Frequency of CRRT and PPH sessions that will be required for each patient.
Measured: 30 days
Vasopressors
Requirement of vasopressors and or inotropic support.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aluminium Phosphide PoisoningStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between using CRRT versus plasmapheresis in the management of aluminum phosphide poisoning and effect on mortality rate.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Ahmed Samy Anwer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334667
- Sponsor's protocol ID
- Aluminum phosphide poisoning
- Acronym
- AlP
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan LT, Crowley RJ, Delliou D, Geyer R. Phosphine analysis in post mortem specimens following ingestion of aluminium phosphide. J Anal Toxicol. 1983 Jul-Aug;7(4):165-7. doi: 10.1093/jat/7.4.165.
PubMed 6314042Yan H, Chen H, Li Z, Shen M, Zhuo X, Wu H, Xiang P. Phosphine Analysis in Postmortem Specimens Following Inhalation of Phosphine: Fatal Aluminum Phosphide Poisoning in Children. J Anal Toxicol. 2018 Jun 1;42(5):330-336. doi: 10.1093/jat/bky005.
PubMed 29378027Navabi SM, Navabi J, Aghaei A, Shaahmadi Z, Heydari R. Mortality from aluminum phosphide poisoning in Kermanshah Province, Iran: characteristics and predictive factors. Epidemiol Health. 2018 May 27;40:e2018022. doi: 10.4178/epih.e2018022. eCollection 2018.
PubMed 29807406Bellomo R, Ronco C. Nomenclature for continuous renal replacement therapies. Critical Care Nephrology: Springer; 1998. p. 1169-76.
Ronco C, Ricci Z. Renal replacement therapies: physiological review. Intensive Care Med. 2008 Dec;34(12):2139-46. doi: 10.1007/s00134-008-1258-6. Epub 2008 Sep 13.
PubMed 18791697Macedo E, Mehta RL. Continuous Dialysis Therapies: Core Curriculum 2016. Am J Kidney Dis. 2016 Oct;68(4):645-657. doi: 10.1053/j.ajkd.2016.03.427. Epub 2016 May 28. No abstract available.
PubMed 27241853Schutt RC, Ronco C, Rosner MH. The role of therapeutic plasma exchange in poisonings and intoxications. Semin Dial. 2012 Mar-Apr;25(2):201-6. doi: 10.1111/j.1525-139X.2011.01033.x. Epub 2012 Feb 22.
PubMed 22353434
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Continuous Renal Replacement Therapy Versus Plasmapheresis on Mortality Rate in Aluminum Phosphide Poisoning; Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05334667
- Acronym / sponsor ID
- AlP / Aluminum phosphide poisoning
- Conditions
- Aluminium Phosphide Poisoning
- Keywords
- CRRT, Plasmapheresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aluminum phosphide (AlP) is a solid fumigant pesticide sold as tablets in use since the 1940s. It is considered to be an ideal pesticide because of its cheapness, efficiency, and easy availability in the market and is widely used as a grain preservative worldwide.The mortality in cases of aluminum phosphide poisoning varies between 60% and 90%, even in experienced and well-equipped hospitals. Patients mostly die due to cardiovascular collapse, refractory shock, severe acidemia, fulminant hepatic failure, and or adult respiratory distress syndrome.
Continuous renal replacement therapy (CRRT) is a slow and smooth continuous extracorporeal blood purification, which is designed to replicate depurative function of the kidney. It is usually implemented over 24 h to several days with an aim of gentle correction of fluid overload and removal of excess uremic toxins. Furthermore, many observational studies considered CRRT as the predominant form of RRT in the intensive care unit (ICU) for critically ill patients with AKI and/or multiorgan failure, along with acute brain injury or other causes of increased intracranial pressure or generalized brain edema. The effectiveness of CRRT is mainly due to its accurate volume control, steady acid-base and electrolyte correction, and achievement of hemodynamic stability in adults and pediatrics.
Plasmapheresis (PPH) can rapidly and effectively remove toxic substances and their potentially toxic metabolites from the blood compartment, especially those with high protein-binding. As the potential benefit of therapeutic plasma exchange is increasingly recognized, its use is becoming more widespread, and case reports have confirmed its value in the treatment of drug overdose. The application of plasmapheresis dramatically reversed the severe biochemical and clinical manifestations and was able to prevent serious co-occurrence.
Detailed description
Seventy five (75) patients will be included in this study. They will be randomly allocated into three groups (25 patients | each)
- Control Group (C Group): routine management.
- CRRT Group: routine management + CRRT.
- PPH Group: routine management + PPH.
Immediately after ICU admission:
All Patients will receive the routine management including:
- Care for airway, breathing and circulation.
- Intravenous fluids guided by central venous pressure measurement and vasopressors (Norepinephrine) IV infusion will be used to treat hypotension and refractory shock, intubation and mechanical ventilation in the following conditions: apnea, respiratory failure, hypoxia, inadequate ventilation, disruption of airway reflexes, disturbed conscious level (GCS <8).
- Phosphine excretion can be increased by maintaining adequate hydration and renal perfusion with intravenous fluids and low dose dopamine (4-6 μg/kg/min). Diuretics like furosemide can be given if systolic blood pressure is >90 mm Hg to enhance excretion as the main route of elimination of phosphine is renal.
- Correction of metabolic acidosis by intravenous sodium bicarbonate will also be considered in a dose of 50-100 mEq intravenously every 8 hour till the bicarbonate level rises to 18-20 mEq/L.
- Additionally, magnesium sulfate: 1g IV infusion every 1hr for the first 3 hrs, followed by 1-1.5 g every 6 hrs for 24 hrs was administered.
- Decontamination will be done by gastric lavage using normal saline mixed with sodium bicarbonate solution (2 ampoules sodium bicarbonate 25% added to each 500cc saline) in all Patients presented within 2 hrs of toxic ingestion. Then, a single (50 gm) dose of activated charcoal will be administered.
Then patients will receive either CRRT or PPH after confirmation of exposure to aluminum phosphide.
Peri-interventional evaluation: -
- Time elapsed between exposure and start of management.
- Standard vital signs (ABP, HR, Spo2, ETCO2). ECG and GCS are continuously monitored and documented.
- Laboratory studies:
- Phosphine gas level in blood by gas chromatography: on admission and another sample after CRRT or PPH
- Tropnin levels immediately on admission and at the end of CRRT or PPH.
- ABG to assess acid base status and lactate levels. Basic sample on admission and serial samples every 2 hours after the start of CRRT or PPH for follow up, evaluation and assessment.
Prisma-flex (Gambro-Swedan) machine will be used to carry out both CRRT and PPH sessions. Each CRRT session continue for 72 hours, while PPH session continue for 4 hours. The need for another session will be evaluated by the SBP< 90 mmHg, lactate level >1mmol, acid base status; PH<7.35 and renal function; S. creatinine>2.
All participating patients will be observed until discharge from the hospital or death. Continuous monitoring and documentation of their vital signs, oxygen saturation, and conscious level will be done.
Parameters to be evaluated regularly
- Laboratory studies
- CBC, Coagulation profile (PT, PC, INR) if within normal, reassessment after 48 hours.
- Liver function tests LFTs if within normal, reassessment after 48 hours.
- Urea and creatinine will be assessed daily.
- Troponin T and I if within normal, reassessment after 48 hours.
- Blood glucose/ 4 hours for the first 48 hours then every 8 hours.
- K, Mg, Ca will be assessed daily.
- Standard monitoring: ABP, HR, Spo2, ETCO2 and ECG continuously.
- 24 hours total urine output (UOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison between using CRRT versus plasmapheresis in the management of aluminum phosphide poisoning and effect on mortality rate.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Routine managementPatients will receive routine management only. |
| CRRT group | Active comparator | Other: Routine management, Device: CRRTPatients will receive CRRT and routine management. |
| PPH group | Active comparator | Other: Routine management, Device: PPHPatients will receive plasmapheresis and routine management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients exposed to AlP poisoning of either sex.
- Critically ill with severe symptomatic acute AlP poisoning; SBP<90mmHg, PH<7.32 and HR<60 bpm.
- Age >18 year.
Key exclusion criteria (2 listed)
- Refusal to consent participating research.
- Age <18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine managementRoutine management | Other | CRRT group, Control group, PPH group |
| CRRTPrisma-flex (Gambro-Swedan) machine will be used to carry out both CRRT and PPH sessions. Each CRRT session continue for 72 hours, while PPH session continue for 4 hours. | Device | CRRT group |
| PPHPrisma-flex (Gambro-Swedan) machine will be used to carry out both CRRT and PPH sessions. Each CRRT session continue for 72 hours, while PPH session continue for 4 hours. | Device | PPH group |
Primary outcome
Mortality rate
Time frame: 30 days
Evaluation of the effect of CRRT versus PPH on mortality rate in acute AlP poisoning, (30 days mortality).
4 secondary outcomes
ICU
Time frame: 30 days
Morbidity
Time frame: 30 days
Sessions
Time frame: 30 days
Vasopressors
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 6314042Chan LT, Crowley RJ, Delliou D, Geyer R. Phosphine analysis in post mortem specimens following ingestion of aluminium phosphide. J Anal Toxicol. 1983 Jul-Aug;7(4):165-7. doi: 10.1093/jat/7.4.165.
- Background: PubMed 29378027Yan H, Chen H, Li Z, Shen M, Zhuo X, Wu H, Xiang P. Phosphine Analysis in Postmortem Specimens Following Inhalation of Phosphine: Fatal Aluminum Phosphide Poisoning in Children. J Anal Toxicol. 2018 Jun 1;42(5):330-336. doi: 10.1093/jat/bky005.
- Background: PubMed 29807406Navabi SM, Navabi J, Aghaei A, Shaahmadi Z, Heydari R. Mortality from aluminum phosphide poisoning in Kermanshah Province, Iran: characteristics and predictive factors. Epidemiol Health. 2018 May 27;40:e2018022. doi: 10.4178/epih.e2018022. eCollection 2018.
- BackgroundBellomo R, Ronco C. Nomenclature for continuous renal replacement therapies. Critical Care Nephrology: Springer; 1998. p. 1169-76.
- Background: PubMed 18791697Ronco C, Ricci Z. Renal replacement therapies: physiological review. Intensive Care Med. 2008 Dec;34(12):2139-46. doi: 10.1007/s00134-008-1258-6. Epub 2008 Sep 13.
- Background: PubMed 27241853Macedo E, Mehta RL. Continuous Dialysis Therapies: Core Curriculum 2016. Am J Kidney Dis. 2016 Oct;68(4):645-657. doi: 10.1053/j.ajkd.2016.03.427. Epub 2016 May 28. No abstract available.
- Background: PubMed 22353434Schutt RC, Ronco C, Rosner MH. The role of therapeutic plasma exchange in poisonings and intoxications. Semin Dial. 2012 Mar-Apr;25(2):201-6. doi: 10.1111/j.1525-139X.2011.01033.x. Epub 2012 Feb 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Routine management, CRRT and PPH in people with Aluminium Phosphide Poisoning, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334667, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.