Organophosphate induced delayed neuropathy after an acute cholinergic crisis in self-poisoning.

INTRODUCTION: Despite organophosphate pesticide is the most prevalent cause of acute poisoning in low- and middle-income countries, data on organophosphate induced delayed neuropathy (OPIDN) are limited. We aimed to characterize organophosphates' long-term effects on the peripheral nervous system after an acute cholinergic crisis in adults. METHODS: We performed a prospective observational study in an academic hospital of north India in patients aged 13-40 years with acute organophosphate ingestion. After resolving the cholinergic crisis, the patients were followed for six months with neurologic assessments, including history, neurologic examination, and nerve conduction study (NCS). RESULTS: Twenty-three patients were recruited to the study. All but one had normal neurological examination and NCS at discharge from hospital a median duration of six days (interquartile range, 3-10) after self-poisoning. Eight (34.8%) developed OPIDN during the six-month follow-up. Three patients had symptomatic neuropathy, and NCS detected subclinical peripheral nerve involvement in five. All cases were associated with chlorpyrifos ingestion (8/17 total chlorpyrifos cases). Two OPIDN cases had foot drop and gait ataxia at three-month which persist at six-month. One patient had distal paresthesia at three months, which improved at a six-month follow-up. NCS in OPIDN cases invariably revealed axonal degeneration, injury to motor fibers more than sensory fibers, and frequent peroneal nerve involvement. None of the baseline characteristics, including the ingested amount, predicted clinical or subclinical OPIDN in chlorpyrifos self-poisoned patients on a univariant analysis. CONCLUSION: Peripheral nerve involvement is not uncommon after recovery from a cholinergic crisis in chlorpyrifos self-poisoning and debilitating in some patients. Detection of subclinical injury on NCS may provide an early window to prevent severe symptomatic neuropathy.

Glucose-insulin-potassium infusion for the treatment of acute aluminum phosphide poisoning: an open-label pilot study.

Introduction: Acute aluminum phosphide poisoning is common in low- and middle-income countries, and is associated with very high case fatality. The addition of glucose-insulin-potassium (GIK) infusion to the standard supportive care has been proposed to improve outcomes. We aimed to assess the effectiveness of GIK infusion in acute aluminum phosphide toxicity.Methods: We performed a prospective open-label pilot study in a tertiary care hospital in north India in patients over 13 years of age with acute aluminum phosphide poisoning, to determine whether the treatment with GIK infusion improved outcomes. The primary outcome was in-hospital case fatality, and the secondary outcomes were the duration of hospital stay, the requirement of mechanical ventilation, and the change in hemodynamic and metabolic parameters.Results: A total of 60 patients were randomly assigned to groups that received either GIK infusion with supportive care or supportive care alone. Baseline parameters in both groups were comparable. Treatment with GIK infusion was associated with significantly lower in-hospital case fatality compared with supportive care alone (46.7% versus 73.3%; p-value 0.03). It was associated with a longer duration of hospital stay (p-value < 0.01) and reduced requirement of mechanical ventilation (p-value < 0.01). The treatment improved blood pressure (systolic, diastolic, and mean arterial pressure) and Glasgow coma scale score at various time intervals; however, pulse rate and metabolic acidosis (blood pH and bicarbonate levels) remained comparable in both the groups. Hyperglycemia was significantly higher in the GIK group but was easily managed.Conclusion: Treatment with GIK infusion may improve survival and hemodynamics in patients with acute aluminum phosphide poisoning.

Development of tool for the assessment of comprehension of informed consent form in healthy volunteers participating in first-in-human studies.

Informed consent is a process that involves providing all pertinent study information to the potential study participant. The information imparted in the form gives all such information as would enable a potential participant to come to a decision regarding his/her participation in the study. Various study related aspects are outlined in the participant information leaflet including the background of the study, the benefits and risks, treatment alternatives; the methodology of the study, follow up schedules, confidentiality of the data, compensations and remunerations and right to not participate or withdraw from the study. We have continued a similar exercise for a phase I, first-in-human study, conducted by our center. Here, the volunteers were asked certain questions pertaining to the trial background, design, patients' rights and miscellaneous categories. They were then assessed and the scores compared to come up with certain conclusions. The median (range) for the entire comprehension score was calculated and statistically analyzed on various aspects. Readability of the ease of reading of the consent form was also analyzed on a Flesch-Kinkaid reading scale. A total of 69 volunteers were screened out of which 50 were enrolled in the study. The median (range) score was 27 (19 to 33) and the mean (S.D.) score was 28.9 (3.1). The maximum correct responses were observed for the questions falling under the volunteers' rights category. The Flesch reading ease score was 54 and the Flesch-Kincaid Grade level score was 9.8. Investigators may be encouraged to incorporate such tools in their informed consent process.