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临床试验/NCT05311410
NCT05311410招募中不适用

Viral Kinetics of SARS-CoV-2 in Patients in the Intensive Care Unit Undergoing Dental Procedures

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Increased quantification of viral replication

研究概览

简要总结

The prevalence and clinical relevance of viremia in patients with COVID-19 have not been well investigated. Seeking to understand the need for dentistry to perform bloody procedures in critically ill patients with COVID-19 admitted to the ICU, the quantification of the magnitude of viral replication may play a fundamental role in this scenario. For this, it is necessary to study the viremia kinetics of SARS-CoV-2, seeking to assess whether there is any characteristic pattern that may be associated with a worse clinical outcome of the patient with COVID-19 after undergoing bloody dental procedures, therefore, the objective of this research will be to investigate the occurrence of viral kinetics produced by dental procedures in patients with SARS-CoV-2 in Intensive Care Units, where, in addition to analyzing the oral health condition, the viral kinetics of SARS-CoV-2 will also be investigated by means of reverse transcription polymerase chain reaction (RT-PCR) examination of blood samples from patients with COVID-19 undergoing bloody dental treatment. This research is expected to identify risks and consequences regarding the possibility of performing bloody dental treatment in patients with COVID-19 in serious condition, in addition to verifying the association of the impact of oral infection foci on this profile of patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 16 and 90 years old who describe subgingival scaling of at least one dental sextant or a tooth extraction.

排除标准

  • Patients who cannot perform clinical examination and/or open dental procedure.

结局指标

主要结局

Increased quantification of viral replication

时间窗: Through three collections of blood samples, in the following moments: (T0) 15 minutes before the beginning of the dental procedure; (T1) 10 minutes after the start of the procedure; and (T3) 10 minutes after the end of the procedure.

The performance of bloody dental procedures hospitalized critically ill patients with COVID-19 causes an increase in the quantification of viral replication, causing changes in the patient's clinical outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Itamara Lucia Itagiba Neves

itamara@incor.usp.br

University of Sao Paulo General Hospital

研究点 (2)

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