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临床试验/CTRI/2020/12/029712
CTRI/2020/12/029712尚未招募不适用

Impact of glycemic variability on the outcome of patients diagnosed with SARS-COV 2 virus

Shravanthi Naidu S Woodayagiri1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
1
主要终点
Clinical recovery of the patient

研究概览

简要总结

The study is prospective and  will take place in the Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur Chennai between November 2020 and November 2022 after obtaining ethical clearance. It aims to study the impact of glycaemic variability on the outcome of patients diagnosed with sars cov-2 virus. Patients diagnosed with SARS COV-2 infection and fit into our inclusion criteria will be enrolled in the study. After obtaining informed consent, a detailed study proforma will be filled and the details of history (including symptoms and duration), clinical findings and lab parameters will be noted down. Treatment details including the drugs used with dosage and duration, reports of blood investigations and other tests, any complication or adverse event, details of hospitalization and outcome would be documented till discharge. Patients will further be classified according to their HbA1C levels as: Good control (<7%) 2.  Poor control (>7%). Every day CBG will be taken thrice daily. The highest and lowest CBG value, along with the average CBG value will be noted down. Any event requiring shift to the HDU/ICU, ARDS, death, prolonged hospitalization, spO2 <90% will be documented as a major adverse event. Requirement of oxygen support (spO2<94%) with no other complications will be documented as a minor adverse event. The correlation between patients showing a greater glycemic variability and development of complications will be looked for. The results will be tabulated and analyzed statistically with the help of a statistician to identify its statistical significance.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Patients >18 years who have been diagnosed with SARS COV-2 infection by RTPCR analysis of the nasal swab specimen taken Type2 diabetes and are on treatment Patients with impaired glucose tolerance FBS >100mg/dl but <126mg/dl PPBS >140mg/dl but <200mg/dl Stress induced hyperglycemia Patients with no history of impaired glucose tolerance but have – Newly diagnosed diabetic patients (as per WHO guidelines).

排除标准

  • •Patients <18 years of age with SARS COV-2 infection GDM Patients with chronic illness such as Malignancies Autoimmune disease Chronic disease requiring steroids Smokers.

结局指标

主要结局

Clinical recovery of the patient

时间窗: At baseline at 4 weeks

次要结局

  • complications during the hospital stay and immediately after discharge(At baseline and 4 weeks)

研究者

发起方
Shravanthi Naidu S Woodayagiri
申办方类型
Other [Principal Investigator]

研究点 (1)

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