Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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: -
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:
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
Standard monitoring: ABP, HR, Spo2, ETCO2 and ECG continuously.
24 hours total urine output (UOP).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients will receive routine management only. |
|
| CRRT group | Active Comparator | Patients will receive CRRT and routine management. |
|
| PPH group | Active Comparator | Patients will receive plasmapheresis and routine management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine management | Other | Routine management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Evaluation of the effect of CRRT versus PPH on mortality rate in acute AlP poisoning, (30 days mortality). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU | ICU stay. | 30 days |
| Morbidity | Thirty days morbidity: organ dysfunction secondary to poisoning (e.g. renal failure, pancreatitis, DM). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6314042 | Background | 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. | |
| 29378027 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Comparison between using CRRT versus plasmapheresis in the management of aluminum phosphide poisoning and effect on mortality rate.
Not provided
Not provided
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.
| 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. |
|
| 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. |
|
| 30 days |
| Sessions | Frequency of CRRT and PPH sessions that will be required for each patient. | 30 days |
| Vasopressors | Requirement of vasopressors and or inotropic support. | 30 days |
| 29807406 | 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. |
| Background | Bellomo R, Ronco C. Nomenclature for continuous renal replacement therapies. Critical Care Nephrology: Springer; 1998. p. 1169-76. |
| 18791697 | 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. |
| 27241853 | 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. |
| 22353434 | 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. |