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Not yet recruitingNCT05334667AlPUpdated Apr 19, 2022

CRRT Versus Plasmapheresis in Aluminum Phosphide Poisoning

An interventional study of Routine management and CRRT in Aluminium Phosphide Poisoning, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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)

  1. Control Group (C Group): routine management.
  2. CRRT Group: routine management + CRRT.
  3. 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: -

  1. Time elapsed between exposure and start of management.
  2. Standard vital signs (ABP, HR, Spo2, ETCO2). ECG and GCS are continuously monitored and documented.
  3. Laboratory studies:

    1. Phosphine gas level in blood by gas chromatography: on admission and another sample after CRRT or PPH
    2. Tropnin levels immediately on admission and at the end of CRRT or PPH.
    3. 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

  1. 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.
  2. Standard monitoring: ABP, HR, Spo2, ETCO2 and ECG continuously.
  3. 24 hours total urine output (UOP).
02

Conditions studied

  • Aluminium Phosphide Poisoning

Browse trials for

Keywords

  • CRRT
  • Plasmapheresis
03

In context

Poisoning

209 studies on the registry are indexed under Poisoning; 26 are open to participants now.

This study's planned enrollment of 75 is close to the median of 72 across 104 interventional studies indexed under Poisoning.

Browse Poisoning studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Refusal to consent participating research.
  • Age \<18 years.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Placebo comparator
    Control group

    Patients will receive routine management only.

    Other: Routine management

  • Active comparator
    CRRT group

    Patients will receive CRRT and routine management.

    Other: Routine management · Device: CRRT

  • Active comparator
    PPH group

    Patients will receive plasmapheresis and routine management.

    Other: Routine management · Device: PPH

Interventions

  • OtherRoutine management

    Routine management

  • DeviceCRRT

    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.

  • DevicePPH

    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.

06

What researchers measure

Primary outcomes

  1. Mortality rate

    Evaluation of the effect of CRRT versus PPH on mortality rate in acute AlP poisoning, (30 days mortality).

    Time frame: 30 days

Secondary outcomes

  1. ICU

    ICU stay.

    Time frame: 30 days

  2. Morbidity

    Thirty days morbidity: organ dysfunction secondary to poisoning (e.g. renal failure, pancreatitis, DM).

    Time frame: 30 days

  3. Sessions

    Frequency of CRRT and PPH sessions that will be required for each patient.

    Time frame: 30 days

  4. Vasopressors

    Requirement of vasopressors and or inotropic support.

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 6314042 ↗
  • Yan 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 29378027 ↗
  • Navabi 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 29807406 ↗
  • Bellomo 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 18791697 ↗
  • Macedo 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 27241853 ↗
  • Schutt 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05334667
Lead sponsor
Assiut University
Responsible party
Rabab Ahmed Samy Anwer (Principal investigator, Assiut University) — Principal investigator
First posted
Apr 19, 2022
Start date
Jun 2022 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Apr 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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