Clinical trial NCT06613659: Cohort Study on the Treatment of Severe Pneumonia with Traditional Chinese Medicine
Official title: Cohort Study on the Efficacy of Traditional Chinese Medicine Syndrome Differentiation Scheme in Adjuvant Treatment of Severe Pneumonia Based on the Real World
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Community-Acquired Infections
Keywords: Community-Acquired Infections
Traditional Chinese Medicine
Cohort study
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe community-acquired pneumonia (CAP) is a severe respiratory disease with further development and deterioration of lung tissue inflammation, causing organ dysfunction and even life-threatening. Patients with SCAP are prone to hypoxemia, respiratory failure, septic shock, leading to multiple organ failure and poor prognosis. Western medicine treatment of SCAP mainly focuses on anti infection and mechanical ventilation. Although new intervention measures and management concepts are constantly optimized, the mortality rate of SCAP is still high. The treatment of SCAP is facing a severe situation, so it is necessary to seek new adjuvant therapy.

Brief summary: This is a multicenter, prospective cohort study, with syndrome differentiation and treatment of traditional Chinese medicine as the exposure factor. Patients using syndrome differentiation of traditional Chinese medicine combined with conventional treatment of Western medicine are classified as the treatment cohort of Integrated Chinese and Western medicine, and patients using conventional treatment of Western medicine only are classified as the treatment cohort of Western medicine

Detailed description: Severe pneumonia is a severe respiratory disease with high mortality, many complications and poor prognosis. Traditional Chinese medicine has certain curative effect in the adjuvant treatment of severe pneumonia, but there is a lack of systematic TCM syndrome differentiation scheme and its curative effect evaluation in the real medical environment. The cohort study on the efficacy of TCM syndrome differentiation scheme in the adjuvant treatment of severe pneumonia is conducive to providing new evidence for the optimization and evidence-based evaluation of TCM treatment scheme for severe pneumonia. Therefore, this study took severe pneumonia as the research object, standardized use of traditional Chinese medicine diagnosis and treatment scheme as the exposure factor, carried out a multi center prospective cohort study, used the 90 day mortality, 28 day mortality, treatment failure rate, etc., to evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in the treatment of severe pneumonia, and provided evidence for the application and promotion of traditional Chinese medicine in severe pneumonia.

Eligibility criteria: Inclusion Criteria:

* It met the diagnostic criteria of severe pneumonia;
* Age ≥ 18 years old, regardless of gender.
* Voluntary treatment.
* Sign the informed consent form.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients with mental illness who are unable to cooperate or unwilling to cooperate with follow-up;
* Those who are participating in clinical trials of other drugs;
* Known allergic to therapeutic drugs.

Primary outcomes:
measure: 90-day mortality
timeFrame: Mortality on the 90th day of treatment
Secondary outcomes:
measure: 28-day mortality
timeFrame: Calculate the proportion of patients who died of the disease on the 28th day after discharge
measure: treatment failure rate
timeFrame: Early treatment failure was defined as clinical deterioration within 72 hours of treatment. Late treatment failure between 72 hours and to 28 days.
measure: time to clinical stability
timeFrame: every day in the treatment.
measure: ICU stay time
timeFrame: the 28 days of the treatment phase.
measure: hospitalization time
timeFrame: the 28 days of the treatment phase
measure: Mechanical ventilation time
timeFrame: the 28 days of the treatment phase
measure: SOFA score
timeFrame: The sofa scores of the first, seventh, fourteenth, twenty-first and twenty-eight days of admission and the first, second and third months after discharge were counted.
measure: Quality of life
timeFrame: The scores of the first, seventh, fourteenth, twenty-first and twenty-eight days of admission and the first, second and third months after discharge were counted
measure: TCM syndrome score
timeFrame: The TCM syndrome scores of the first, seventh, fourteenth, twenty-first and twenty-eight days and the first, second and third months after discharge were counted
measure: 90 day readmission rate
timeFrame: The proportion of rehospitalization due to exacerbation within 90 days after discharge was recorded
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
References: