A 15-Year Cohort Study to Analyze Risk Factors for Mortality in Patients With Intestinal Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- All-cause mortality in patients with intestinal tuberculosis.
研究概览
简要总结
This study adopts a combined design of retrospective cohort study followed by prospective observational study, which is conducted at Beijing Chest Hospital. The study first collects and analyzes the data of intestinal tuberculosis patients diagnosed and followed up in the hospital from 2011-1 to 2025-12 (a 15-year retrospective period) as the retrospective cohort, aiming to initially identify the risk factors associated with mortality in patients with intestinal tuberculosis. On the basis of the retrospective analysis results, the study will further carry out a prospective observational study, continuously enroll new intestinal tuberculosis patients, follow up their clinical status, treatment response and mortality outcomes for a certain period, and verify and supplement the risk factors identified in the retrospective stage. Clinical data, including demographic characteristics, clinical manifestations, laboratory test results, treatment regimens, and follow-up outcomes (mortality status), will be collected and sorted out in both stages. Univariate and multivariate statistical analyses will be used to screen and verify potential risk factors (such as age, disease severity, comorbidities, and treatment compliance) that affect the mortality of patients with intestinal tuberculosis. The results of this study are expected to provide scientific evidence for optimizing the clinical management, risk assessment, and prognostic improvement of patients with intestinal tuberculosis, and further guide the formulation of targeted prevention and treatment strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 years old (no upper age limit) at the time of intestinal tuberculosis diagnosis;
- •Diagnosed with intestinal tuberculosis in accordance with clinical diagnostic criteria (combined with clinical manifestations, laboratory examinations, imaging findings, and/or pathological results);
- •For the Retrospective Intestinal Tuberculosis Cohort: diagnosed between January 2011 and December 2025, with complete medical records and follow-up data (including mortality status);
- •For the Prospective Intestinal Tuberculosis Cohort: newly diagnosed, able to cooperate with regular follow-up, and sign the informed consent form (if applicable);
- •No severe cognitive impairment or mental illness that affects the collection of clinical data and follow-up.
排除标准
- •Patients with incomplete diagnosis of intestinal tuberculosis (no clear clinical, laboratory, imaging or pathological evidence to confirm the diagnosis);
- •Patients with concurrent severe extrapulmonary tuberculosis (such as tuberculous meningitis, miliary tuberculosis) that may independently affect mortality outcomes;
- •For the Retrospective Intestinal Tuberculosis Cohort: patients with incomplete medical records or missing key follow-up data (especially mortality status and related risk factor information);
- •For the Prospective Intestinal Tuberculosis Cohort: patients who refuse to sign the informed consent form (if applicable), cannot cooperate with regular follow-up, or are lost to follow-up during the study period;
- •Patients with severe comorbidities that may lead to rapid death (such as advanced malignant tumors, severe heart failure, end-stage liver/kidney disease) within the study period, which may interfere with the analysis of mortality risk factors related to intestinal tuberculosis;
- •Patients with cognitive impairment, mental illness or other conditions that cannot provide effective clinical information or cooperate with the study.
研究组 & 干预措施
Retrospective Intestinal Tuberculosis Cohort
This cohort includes intestinal tuberculosis patients diagnosed and followed up in Beijing Chest Hospital from 2011-01 to 2025-12 (15-year retrospective period). The research data are collected by reviewing historical medical records, mainly used for initial screening of mortality-related risk factors.
干预措施: Observational (Other)
Prospective Intestinal Tuberculosis Cohort
This cohort includes newly diagnosed intestinal tuberculosis patients enrolled continuously after the retrospective stage. The research data are collected through dynamic follow-up of the subjects, mainly used for verifying and supplementing the mortality-related risk factors identified in the retrospective cohort.
干预措施: Observational (Other)
结局指标
主要结局
All-cause mortality in patients with intestinal tuberculosis.
时间窗: For the Retrospective Intestinal Tuberculosis Cohort, the time frame is 15 years, from January 2011 to December 2025; for the Prospective Intestinal Tuberculosis Cohort, the time frame is 3 years from the date of the first patient enrollment
Death of the study subject due to any cause during the study period
次要结局
未报告次要终点
研究者
Xuelian Li
Chief Physician
Beijing Chest Hospital, Capital Medical University