European Journal of Cardiovascular Medicine

Poisoning is a significant public health problem and one of the major causes of hospitalization. Insecticides particularly OP compounds are extensively used in agriculture and are responsible for a significant number of poisoning incidents. High prevalence of poisoning-related admissions highlights the critical need for implementing efficient prevention and treatment measures. Organophosphorus compounds (OPCs) are extensively used in eliminating pests, but they pose danger to humans, being a frequent cause of acute poisoning [1]. The main way organophosphate compounds cause toxicity is by inhibiting AChE, an enzyme crucial for proper CNS function. This causes to the buildup of acetylcholine at synaptic junctions, where nerve cells interact with each other or with muscles[2]. The accumulation of Ach causes overstimulation of cholinergic receptors, which affects both muscarinic and nicotinic receptors [3]. The severity of the symptoms in acute OP poisoning can change significantly based on the factors such as the dose of exposure. Early and appropriate treatment is crucial to mitigate these severe health outcomes and improve patient prognosis [4]. While the immediate treatment focuses on antidotes such as atropine and pralidoxime, and supportive care measures, the presence of secondary complications can influence patient outcomes. One potential complication is pancreatic damage, which may not always show immediate symptoms but can be detected through biochemical markers such as elevated amylase levels [2]. This research aims to evaluate whether increased amylase levels in serum are associated with the severity of organophosphate poisoning by examining the occurrence of hyperamylasemia.

• Study design: A hospital-based, cross-sectional study.

• Study period- 18 months from date of final approval by IEC and IRB and clearance of study by the KUHS.

 • Study area and setting: Government Medical College Hospital, Ernakulam.

 • Study population: The study will be done among in-patients of Department of General Medicine presenting with history of organophosphorus poisoning.

•            Inclusion criteria:

Patients presenting with history of organophosphorus poisoning will be the study subjects.

                        Exclusion criteria: 

•            Patients with double poisoning.

•            Pregnancy.

•            Patients with history of liver disease.

•            Patients with history of intake of drugs likely to produce pancreatitis-      

         Azathioprine 6-Mercaptopurine, Thiazides, Frusemide, Pentamidine, Steroids, valproate Sulphonamides

• Sample size: According to a study conducted by Rohit N. Salame et al in in Shri Vasantrao Naik Government Medical College and Hospital, Yavatmal, 78% had increased serum amylase levels in first 24 hours. Based on this data and using the formula N= 4pq/d2, the minimum sample size for the present study is estimated as 70

Here p-78 and d =10 Therefore, N=4x 78x22/10x10=68.64

N= 70(approximate).

Sampling techniques: All Consecutive cases of patients satisfying inclusion criteria will be included in the study till the sample size is attained.

Study Procedure After obtaining Institutional Ethics Committee clearance all patients satisfying the inclusion criteria for the study will be taken. After informed written consent from the study participants, a detailed history taking and physical examination including general examination and systemic examination will be done and examined for symptoms of organophosphorus poisoning. All basic investigations will be sent. The data will be collected from results of various investigations (including amylase levels), already done as part of treatment of the patient will be entered into the proforma.

•            The severity will be assessed by using the following parameters:

•            Persistent bradycardia

•            Persistent hypotension

•            coma

•            respiratory failure requiring mechanical ventilation

•            death

Data collection tools: A structured proforma to collect information on the medical and clinical history of the participant and investigation Results.

Data Analysis:

•            Data will be entered into MS Excel sheet.

•            Analysed using SPSS statistical software.

•            Quantitative variables will be expressed as mean and standard deviation.

Association between quantitative variables will be done by independent sample t test. Significance level will be fixed at a p value ≤ 0.05.

ETHICAL CONSIDERATIONS:

•            Informed written consent will be obtained from the patient or the bystander.

•            Confidentiality of the subject will be maintained throughout the study.

•            No financial burden will be imposed on the subjects

•              The study will commence only after receiving approval from the Ethics Committee

A tertiary hospital based cross sectional study to estimate the percentage of study subjects with increased serum amylase values in in-patients with OP poisoning in Government Medical College Hospital, Ernakulam. Data was collected from 76 patients who satisfied the inclusion criteria.

General profile of the study subjects

Age

Table 1

Majority of the study subjects belonged to age group > 51 years (55.3 %) followed by 31-40 years (17.1 %) and 41-50 years respectively (15.8 %).

Gender

Majority of the study subjects were males (63, 83 %). There were 13 females (17.1 %)

Fig1 Gender

                                    Distribution of study subjects based on gender

History of alcohol intake

Fig 2 Distribution of study subjects based on history of alcohol intake

Distribution of study subjects based on history of alcohol intake

22 (28.9 %) of the subjects had history of alcohol intake within 24 hours.

Distribution of study subjects based on time between poisoning and admission

Fig 3 Distribution of study subjects based on time between poisoning and admission

It took > 12 hours for majority of the study subjects to get admitted in the hospital (29,38.5 %). Only 20 (26.3 %) reached the hospital in less than 5 hoursDuration of the stay in the hospital

Table 2 Duration of the stay in the hospital

Majority of the study subjects had a duration of stay of 8-14 days (55.3 %)

Symptoms of organophosphorus poisoning

Table 3 Distribution of study subjects based on symptoms present

97.4 % of the study subjects had organophosphorous poisoning symptoms present.

Distribution of study subjects based on symptoms of organophosphorus poisoning

Table 4 Distribution of study subjects based on symptoms of organophosphorus poisoning

81.6 % had persistent bradycardia while 47.4 % and 46.1 % had persistent hypotension and respiratory failure needing MV respectively. 28.9 % of subjects went into coma.

Fig 4. symptoms of organophosphorus poisoning

Final outcomes of organophosphorus poisoning

Table 5 Distribution of study subjects based on outcomes of organophosphorus poisoning

35 (46.1 %) of the study subjects died while 53.9 % had full recovery.

Prevalence of elevated serum amylase levels

Distribution of the study subjects based on elevated levels of serum amylase

Table 6 Distribution of the study subjects based on elevated levels of serum amylase

40 (52.6 % ) of the subjects had high serum amylase levels, while the remaining 47.4 % had normal serum amylase levels. Mean serum amylase levels was 253.18 + /- 227.660. It ranged from 23 to 907.

Association between elevated serum amylase levels and gender of organophosphorus poisoning patients

Table 7. Association between elevated serum amylase levels and gender of organophosphorus poisoning patients

The proportion of elevated serum amylase was higher among males (55.6 %) as compared to female study subjects (38.5 %). The difference was not statistically significant.

Association between elevated serum amylase levels and persistent bradycardia in organophosphorus poisoning patients

Table 8. Association between elevated serum amylase levels and persistent bradycardia in organophosphorus poisoning patients

Prevalence of elevated serum amylase was higher in subjects with persistent bradycardia (61.3 %) when compared with those without persistent bradycardia (14.3 %). The difference was statistically significant (p < 0.05).

Association between elevated serum amylase values and persistent hypotension in organophosphorus poisoning patients

Table 9. Association between elevated serum amylase values and persistent hypotension in organophosphorus poisoning patients

The prevalence of high values of serum amylase was more among patients with persistent hypotension (83.3 %) as compared to those without persistent bradycardia (25 %). The difference was found to be statistically significant (p < 0.05).\

Association between elevated serum amylase levels and coma in organophosphorus poisoning patients

Table 10 Association between elevated serum amylase levels and coma in organophosphorus poisoning patients

The prevalence of elevated amylase level in serum was higher among patients with coma (90.9 %) than those not in coma (37 %). The difference was found statistically significant (p < 0.05).

 Association between elevated serum amylase levels and convulsions in organophosphorus poisoning patients

Table 11. Association between elevated serum amylase levels and convulsions in organophosphorus poisoning patients

95 % of the study subjects with convulsions had elevated amylase level in serum as compared to only 37.5 % in those without convulsions. The difference was found to be statistically significant (p < 0.05).

Association between elevated serum amylase levels and need of mechanical ventilation

Table 12. Association between elevated serum amylase levels and need of mechanical ventilation

Prevalence of elevated serum amylase found higher among the subjects with respiratory failure who needed mechanical ventilation (94.3 %) than those who did not (17.1 %). The difference was found to be statistically significant (p < 0.05).

Association between elevated serum amylase levels and final outcome in organophosphorus poisoning patients

Table 13. Association between elevated serum amylase levels and final outcome in organophosphorus poisoning patients

The prevalence of elevated amylase level in serum was higher among subjects who passed away following OP poisoning (97.1 %) than those who fully recovered (14.6 %). The difference was found statistically significant (p < 0.05).

LIST OF TABLES

LIST OF FIGURES

worldwide health issue, mainly in the areas of agricultural activities. As noted in existing research, organophosphate (OP) poisoning frequently occurs in the Intensive Care Units (ICUs) and is associated with notable number of deaths, which can be mitigated with appropriate treatment. Identifying the key factors influencing mortality and prognosis in OP poisoning can enhance follow-up and treatment strategies in the ICU. The measurement of serum amylase is important in assessing and managing these patients. This study presents a detailed analysis of our findings in relation to other studies conducted both in India as well as abroad. The end point of this research is to evaluate the prevalence of elevated serum amylase values in subjects with acute OP poisoning and to explore the relationship connecting these levels with the severity of poisoning. By understanding these associations, we seek to enhance diagnostic and good therapeutic approaches for managing OP poisoning effectively.

Demographic Profile

The study included 76 patients with OP poisoning, showing a predominance of males (83%) calculating a mean age of 45.7 years. The age distribution disclosed that individuals above 51 years constituted 55.3% of this study population. This particular demographic inclination aligns with the known higher exposure risk among individuals involved in agricultural activities, often leading to increased vulnerability to OP poisoning. The predominance of older adults may be attributed to cumulative exposure over the years, increasing the risk of severe poisoning.

 Age Distribution

The age distribution in this study highlights that older adults, particularly those above 51 years of age, were more frequently affected. This age group may be more vulnerable to severe OP poisoning due to prolonged exposure and cumulative effects over time. In contrast, the studies by Muhammet Guven et al. [5] and AM Saadeh et al. [6] reported mean age of 24.1 and 23.95, respectively. In our study the distribution among elderly underscores the importance of targeted interventions for older populations, who may have less robust physiological defences against toxic exposures. Elderly may also have underlying health problems that can exacerbate the effects of OP poisoning, making them more susceptible to severe outcomes.

Gender Distribution:

The gender distribution on our study subjects was significantly skewed, with males comprising 83%. Similar observations were made by Dalal et al[7] where males constituted 63% of cases of poisoning and 65.3% of cases as observed by Gunosindhu Paul et al[8], reflecting the higher likelihood of males being involved in agricultural work and hence having greater exposure to OP compounds. This demographic insight is crucial for designing targeted public health interventions and safety measures in agricultural settings. Additionally, cultural and social factors may contribute to the higher incidence among males, as they could be more supposable to handle pesticides and involved in high-risk work activities.

Serum Amylase Levels

The study shows a notable prevalence of elevated levels of serum amylase, observed in 52.6% of the patients. Mean value of serum amylase level was 253.18 ± 227.660 U/L, with a range from 23 to 907 U/L. Lee et al. [9] reported that 36% of patients with organophosphate (OP) poisoning exhibited hyperamylasemia. They also found a significant correlation between elevated amylase levels and both the severity of the condition and the onset of shock. In contrast, Singh et al.[10] observed an incidence of hyperamylasemia of 46.95% but did not find a significant link between elevated amylase levels and patient outcomes.

This elevation suggests substantial pancreatic involvement, which could be a direct consequence of the toxic effects of OP compounds or an inflammatory response. The pancreas, rich in cholinergic receptors, is particularly susceptible to the effects of Ach accumulation, leading to pancreatitis. Elevated serum amylase levels in OP poisoning cases highlights the need for comprehensive monitoring of pancreatic function. This result suggests that the serum amylase could serve as a valuable biomarker for assessing the extent of pancreatic involvement and guiding therapeutic interventions. The pathophysiology of pancreatic involvement in OP poisoning involves the overstimulation of cholinergic receptors in the pancreas, leading to excessive secretion of pancreatic enzymes and subsequent pancreatitis.

Association with Clinical Severity

•            Persistent Bradycardia and Hypotension: The association between increased levels of serum amylase and persistent bradycardia (61.3%) and hypotension (83.3%) is particularly concerning. These cardiovascular complications are indicative of severe poisoning and often necessitate intensive care and monitoring. The underlying mechanism may involve direct effects of Ach on cardiac cells and vascular smooth muscles, exacerbating the cardiovascular instability. Persistent bradycardia and hypotension reflect the severity of cholinergic overstimulation and its impact on cardiovascular function.

 • Neurological Manifestations: The higher prevalence of coma (90.9%) and convulsions (95%) in subjects with increased levels of serum amylase suggests a strong link between pancreatic dysfunction and severe neurological impairment. The cholinergic overstimulation caused by OP compounds likely exacerbates CNS effects, leading to these severe neurological manifestations. Neurological impairment in OP poisoning can fluctuate from mild confusion to severe coma and convulsions, significantly impacting patient outcomes.

•            Respiratory Complications: The finding that 46.1% of subjects who ended up needing mechanical ventilation for respiratory failure highlights the critical nature of respiratory complications in OP poisoning. Similar finding was observed by Eddleston et al [11] Srilanka (2006) reported that 24% of subjects required ventilation. Early diagnosis of respiratory failure, prompt endotracheal intubations and mechanical ventilation are lifesaving in severe OP poisoning. The strong connection between elevated serum amylase levels and respiratory failure underscores the necessity for vigilant monitoring of respiratory function and prompt intervention to manage airway compromise effectively. Respiratory failure is an important cause of mortality in OP poisoning and requires timely and aggressive management.

 • Alcohol Intake A notable observation was that 28.9% of subjects had the history of recent alcohol intake. Alcohol consumption can exacerbate the toxic effects of OP compounds, complicating the clinical course and potentially worsening outcomes. This highlights the need to consider co-morbid conditions and substance use history in the management of OP poisoning. Alcohol intake may enhance the toxicity of OP compounds by altering their pharmacokinetics or by increasing the sensitivity of the nervous system to Ach.

Alcohol consumption may also impair the body's ability to detoxify OP compounds, leading to higher levels of toxicity. Additionally, alcohol can exacerbate the effects of OP poisoning on the liver and pancreas, increasing the risk of hepatic and pancreatic complications. This finding underscores the relevance of assessing alcohol use in patients with OP poisoning and considering its potential impact on the clinical course and outcomes.

•            Mortality Rate This study observed an increased mortality rate of 46.1%, similar to the observations of other studies. This increased mortality rate focuses on the severe nature of OP poisoning and the timely need for proper medical interventions. The correlation between increased serum amylase levels and mortality further underscores the prognostic value of this biomarker, concluding that subjects who has higher levels of serum amylase are at a significantly greater risk of adverse outcomes. Mortality in OP poisoning is often due to respiratory failure, cardiovascular collapse, and severe neurological impairment, highlighting the multifaceted nature of the toxicity. In research conducted in Iran by Zobeiri [12], an increase in plasma amylase levels, exceeding 60% above the normal upper limit at the time of admission, was linked to greater clinical severity and higher mortality rates following organophosphate poisoning. Similarly, a study by Patil et al. [13] in India found elevated amylase levels in all cases of organophosphate poisoning, with significantly higher average serum amylase values observed in subjects who could not survive compared to those who were discharged.

Clinical Implications

Elevated amylase levels in serum can serve as an early marker for identifying patients at risk of severe OP poisoning. This can help prioritize intensive care and monitoring for high-risk patients, potentially improving outcomes through timely intervention. Early identification of severe cases is crucial for initiating aggressive treatment protocols, reducing the risk of complications, and improving survival rates. Routine measurement of serum amylase levels in patients with OP poisoning can aid in the early detection of pancreatic involvement. This is critical for timely intervention and management, reducing the risk of severe complications such as pancreatitis. Monitoring pancreatic involvement can guide the use of specific therapeutic interventions, such as pancreatic enzyme inhibitors and supportive care measures. Understanding the association between elevated serum amylase levels and clinical severity can inform treatment strategies, including the need for aggressive management of cardiovascular, neurological, and respiratory complications. Elevated serum amylase levels can be used as a prognostic marker to predict outcomes and guide clinical decision-making. Subjects with predominantly increased levels may require intensified interventions along with longer duration of hospital stays. The high prevalence of OP poisoning, particularly in agricultural regions, underscores the requirement of public health strategies aimed at educating communities about safe handling practices and the risks associated with OP compounds. Efforts to reduce exposure and improve access to medical treatment can impact the prevalence and severity of OP poisoning significantly.

 In conclusion, the study highlights the high prevalence of elevated serum amylase levels in patients with OP poisoning and their significant association with severe clinical outcomes. Elevated serum amylase levels can serve as a valuable biomarker for assessing the severity of OP poisoning, guiding clinical management, and predicting patient outcomes especially in resource limited setting like ours. Future research programmes should target on establishing standardized protocols for including the use of serum amylase levels as a marker in the management of OP poisoning. Further, health programmes should aim to improve awareness, education, and preventive measures to reduce the incidence and impact of OP poisoning. Enhanced early detection and prompt treatment can ultimately reduce mortality and improve patient outcomes in cases of OP poisoning.

LIMITATIONS OF THE STUDY

While our study provides valuable insights, some limitations are there. Due to limitations in funding and laboratory resources, the study was conducted with a relatively small sample size. Expanding the research to include a bigger cohort would provide a wholesome understanding of the connection between serum amylase levels and the clinical severity and outcomes of organophosphate poisoning. The single-center nature of our study limits the generalizability of the findings. While I attempted to control various confounders, our study could have been affected by many other factors that were not measured.The chemical nature of OP compounds could not be determined due to the unavailability of the facility.

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8.          DOI: http://dx.doi.org/10.18203/2349-3933.ijam20210591

Gunosindhu Paul1 , Mohammed Ruhul Kabir2 , A. B. M. Kamrul-Hasan3*, S. K. Kabir Ahammed4 , M. Enayet Hossain4 , Ferdaus Ahammed4 , Shishir Kumar Basak4 , A. F. M. Nazmul Islam5

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