CRRT Versus Plasmapheresis in Aluminum Phosphide Poisoning

NCT05334667 | Unknown

• 1 other identifier: Aluminum phosphide poisoning
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aluminium Phosphide Poisoning

Keywords

CRRT; Plasmapheresis

Outcome Measures

Primary Outcomes (1)

• Mortality rate

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

  30 days

Secondary Outcomes (4)

• ICU

  30 days

• Morbidity

  30 days

• Sessions

  30 days

• Vasopressors

  30 days

Study Arms (3)

Control group

PLACEBO COMPARATOR

Patients will receive routine management only.

Other: Routine management

CRRT group

ACTIVE COMPARATOR

Patients will receive CRRT and routine management.

Other: Routine management; Device: CRRT

PPH group

ACTIVE COMPARATOR

Patients will receive plasmapheresis and routine management.

Other: Routine management; Device: PPH

Interventions

Routine management OTHER

Routine management

CRRT group; Control group; PPH group

CRRT DEVICE

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.

CRRT group

PPH DEVICE

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.

PPH group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 6314042 BACKGROUND

• 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.

  PMID: 29378027 BACKGROUND

• 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.

  PMID: 29807406 BACKGROUND

• Bellomo R, Ronco C. Nomenclature for continuous renal replacement therapies. Critical Care Nephrology: Springer; 1998. p. 1169-76.

  BACKGROUND

• 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.

  PMID: 18791697 BACKGROUND

• 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.

  PMID: 27241853 BACKGROUND

• 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.

  PMID: 22353434 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The trial will be planned that neither the doctors (investigator) nor the patients will be aware of the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Comparison between using CRRT versus plasmapheresis in the management of aluminum phosphide poisoning and effect on mortality rate.

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share