Herpes Simplex Virus Type 1 Infection/Reactivation of Patients With Severe Pneumonia（the HSV-SP Study）

Официальное название

Prognostic Effect of Herpes Simplex Virus Type 1 Infection/Reactivation in the Lower Respiratory Tract of Critical Care Patients With Severe Pneumonia（the HSV-SP Study）: a Study Protocol for a Multicenter, Prospective Cohort Study

Обзор

Severe pneumonia(SP) is a one of the main causes of death for critically ill patients.Samples of bronchoalveolar lavage fluid (BALF) from SP patients often report positive for herpes simplex virus type 1 (HSV-1) DNA. However, to date, it is unclear the impact and significance of this positive result on SP patients. This study will evaluate the prognostic impact of lower respiratory tract HSV-1 infection/reactivation on ICU severe pneumonia patients.At the same time, by analyzing the risk factors that affect prognosis, we will identify populations with the potential for intervention benefits and provide a basis for further intervention treatment.

Вмешательства

• Диагностический тест Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy
  Bronchoalveolar Lavage (BAL) via Fiberoptic Bronchoscopy 1. Site selection: For patients with limited lesions, the lesion segment was chosen; For patients with diffuse lesions, the right middle lobe or left upper lobe tongue should be severed. 2. Injecting physiological saline: After the top of the bronchoscope is embedded in the target bronchial segment or subsegment opening, 37 ℃ or room temperature physiological saline is rapidly injected through the operating channel, with a total volume of
• Диагностический тест throat Swab
  A throat swab is a diagnostic sampling technique used to collect microbial specimens from the oropharynx and tonsillar areas. The standardized procedure involves: 1. Positioning the patient with their head tilted slightly backward; 2. Using a sterile, synthetic-fiber swab with a plastic shaft (avoiding calcium alginate or wooden shafts); 3. Vigorously rubbing the swab over both tonsillar pillars and the posterior pharyngeal wall while avoiding contact with the tongue, teeth, or uvula; 4. Immedi

Первичные конечные точки

• 30 day mortality rate of critical care patients with severe pneumonia. [Срок оценки: From enrollment (Day 1) through Day 30]

Вторичные конечные точки (3)

• The incidence rate of herpes simplex virus type 1 infection/reactivation in the lower respiratory tract of critical care patients with severe pneumonia [Срок оценки: From enrollment (Day 1) through Day 30]
• ICU mortality and in-hospital mortality , ICU stay time and length of in-hospital stay [Срок оценки: From enrollment (Day 1) through the entire ICU stays and in-hospital stays]
• success rate of ventilator withdrawal, ICU non ventilator survival time [Срок оценки: From enrollment (Day 1) through Day 30]

Критерии участия

Критерии включения

• 1: Age>18 years old. 2: Clinical diagnosis for severe pneumonia. 3: ICU stay time >72 hours. 4: A written informed consent form was obtained from the members of the patients' family.

Критерии исключения

• 1: severe ventilation dysfunction, and effective respiratory support has not been used; 2: Aortic aneurysm and esophageal varices at risk of rupture; 3: Recent acute coronary syndrome, uncontrolled severe hypertension, and malignant arrhythmia; 4: Irreversible bleeding tendencies, such as severe coagulation dysfunction, massive hemoptysis, or gastrointestinal bleeding; 5: Multiple pulmonary bullae at risk of rupture. 6: Estimated survival time<24 hours. 7: Included in another interventional clinical study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06936683 · MR-44-24-013041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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