CRRT Versus Plasmapheresis in Aluminum Phosphide Poisoning (AlP)

April 12, 2022 updated by: Rabab Ahmed Samy Anwer, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Patients will receive routine management only.
Other: Routine management
Routine management
Active Comparator: CRRT group
Patients will receive CRRT and routine management.
Other: Routine management
Routine management
Device: CRRT
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.
Active Comparator: PPH group
Patients will receive plasmapheresis and routine management.
Other: Routine management
Routine management
Device: PPH
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 30 days
Evaluation of the effect of CRRT versus PPH on mortality rate in acute AlP poisoning, (30 days mortality).
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU
Time Frame: 30 days
ICU stay.
30 days
Morbidity
Time Frame: 30 days
Thirty days morbidity: organ dysfunction secondary to poisoning (e.g. renal failure, pancreatitis, DM).
30 days
Sessions
Time Frame: 30 days
Frequency of CRRT and PPH sessions that will be required for each patient.
30 days
Vasopressors
Time Frame: 30 days
Requirement of vasopressors and or inotropic support.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aluminum phosphide poisoning

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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