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临床试验/CTRI/2024/08/072833
CTRI/2024/08/072833尚未招募不适用

Clinical profile of hypoglycaemic patients presenting in emergency room

AIIMS Patna1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To assess and evaluate the clinical profile of hypoglycemic patients presenting to ED.

研究概览

简要总结

Hypoglycemia is a leading cause of emergency department (ED) visits, particularly in patients with diabetes undergoing intensive blood glucose control. Common symptoms include sweating, dizziness, confusion, and in severe cases, loss of consciousness and seizures. While most studies focus on diabetic patients, hypoglycemia also occurs in non-diabetic individuals due to factors such as prolonged starvation, infections, and organ diseases.

The study aims to assess the clinical profile and underlying causes of hypoglycemia in both diabetic and non-diabetic patients presenting to the ED, filling a gap in current literature, especially regarding non-diabetic cases. The primary objective is to evaluate the clinical characteristics of hypoglycemic patients in the ED. Secondary objectives are to determine the incidence of hypoglycemia in diabetic vs. non-diabetic patients, assess cognitive function post-treatment, and document hypoglycemia-related morbidity and mortality.

This prospective, observational study will be conducted at AIIMS Patna over six months, involving patients aged 16 and above with a random blood sugar (RBS) level below 70 mg/dl. Data on demographics, symptoms, causes, treatment, and outcomes will be collected and analyzed. Cognitive function will be assessed using the Mini-Mental Status Examination (MMSE) after treatment.

Expected Outcomes are that this study is expected to provide insights into the clinical presentation of hypoglycemia in the ED, identify associated factors, and contribute to the knowledge base for healthcare professionals managing hypoglycemic episodes.

Prospective and observational, with a sample size of at least 100 patients, using consecutive sampling. The study will include all eligible patients with hypoglycemia during the study period.

研究设计

研究类型
Observational

入排标准

年龄范围
16.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with RBS less than 70 mg/dl on arrival to ED
  • Patients with age more than 16 years.

排除标准

  • Patient refusal to study.

结局指标

主要结局

To assess and evaluate the clinical profile of hypoglycemic patients presenting to ED.

时间窗: 6 hours to 7 days

次要结局

  • To assess the incidence of hypoglycaemia in diabetic & non-diabetic patients presenting to ED.(To assess the cognitive functions using mini mental status examination (MMSE) scale after treatment.)

研究者

发起方
AIIMS Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Deepak Kumar

AIIMS Patna

研究点 (1)

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