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临床试验/CTRI/2024/07/071482
CTRI/2024/07/071482已完成不适用

To study clinical and biochemical parameters in predicting the severity of OP poisoning patients

Department of General Medicine1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2024年8月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Correlation of clinical profile, serum amylase, lipase, plasma cholinesterase, and creatine phosphokinase with severity of organophosphorus poisoning

研究概览

简要总结

The study will recruit all cases that are 18 years and older of organophosphorus poisoning within 48 hours of poisoning, confirmed by history, circumstantial evidence of poisoning, specific clinical examination, and basic laboratory reports. Patients with mixed poisoning, chronic liver disease, chronic kidney disease, chronic pancreatitis, chronic alcohol intake, pregnancy, and patients with malignancy or metastasis will be excluded from the study.

Objectives of the study -

  1. To study the clinical profile and its correlation with biomarkers in organophosphorus poisoning.

  2. To study the correlation of serum amylase, lipase, creatine phosphokinase, and plasma cholinesterase with organophosphorus poisoning outcome.

  3. To study association between time intervalfrom poisoning to intervention ( atropine administeration and gastric lavage ) with the outcome in OP poisoning .

  4. To study the significance of QT interval as a prognostic factor in acute organophosphorus poisoning.

Clinical data and the lab parameters done during admission and ECG changes will be documented in a data proforma.

Consent will be taken from the patient after explaining to him/her the nature of the study. However, if the patient is not in a condition to give consent, the consent would be obtained from next of kin, either spouse,parent, or guardian .

All the patients admitted to the Kasturba Hospital with organophosphorus poisoning will be followed for the clinical outcome. only one admission of the patient during the study period will be considered.

Clinical outcomes will be assessed by Duration of hospitalization in days, requirement and duration of mechanical ventilation, and whether survived or expired.

Peradeniya Organophosphorus poisoning scale will be used for grading of poisoning of the patients. Microsoft Excel sheet will be used for compilation and SPSS software will be used for statistical analysis.

As this study is purely observational, patient management will be chosen by patient-physician without any intervention from the study investigators.

The duration of the study is expected to be 2 years.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All cases of organophosphorus poisoning within 48 hours of poisoning, confirmed by history, circumstantial evidence of poisoning, specific clinical examination, and basic laboratory reports.

排除标准

  • Patients with a history of intake of organophosphorus compound mixed with any other poison or alcohol.
  • Patients having chronic alcohol intake.
  • Patients who are a known case of chronic liver disease.
  • Patients with chronic renal failure or any other renal disorders.
  • Patients with chronic pancreatitis of any etiology.
  • Patients with diseases of the salivary gland.
  • Pregnant females.

结局指标

主要结局

Correlation of clinical profile, serum amylase, lipase, plasma cholinesterase, and creatine phosphokinase with severity of organophosphorus poisoning

时间窗: Prospective observational study | Outcome to be assessed at baseline and at 5 days of admission

次要结局

  • 1. Study of outcome concerning the time interval between poisoning & initiation of treatment(2. Significance of QT interval as a prognostic factor in organophosphorus poisoning)

研究者

发起方
Department of General Medicine
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Divyam Suri

Kasturba Medical College, Manipal

研究点 (1)

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