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
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.
Seventy five (75) patients will be included in this study. They will be randomly allocated into three groups (25 patients \| each)
Immediately after ICU admission:
All Patients will receive the routine management including:
Then patients will receive either CRRT or PPH after confirmation of exposure to aluminum phosphide.
Peri-interventional evaluation: -
Laboratory studies:
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
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 →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.
Exclusion Criteria:
Patients will receive routine management only.
Other: Routine management
Patients will receive CRRT and routine management.
Other: Routine management · Device: CRRT
Patients will receive plasmapheresis and routine management.
Other: Routine management · Device: PPH
Routine management
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.
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.
Mortality rate
Evaluation of the effect of CRRT versus PPH on mortality rate in acute AlP poisoning, (30 days mortality).
Time frame: 30 days
ICU
ICU stay.
Time frame: 30 days
Morbidity
Thirty days morbidity: organ dysfunction secondary to poisoning (e.g. renal failure, pancreatitis, DM).
Time frame: 30 days
Sessions
Frequency of CRRT and PPH sessions that will be required for each patient.
Time frame: 30 days
Vasopressors
Requirement of vasopressors and or inotropic support.
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
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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Assiut University