Analysis of the Efficacy of Hyperbaric Oxygen-assisted Treatment for Acute Severe Ulcerative Colitis and Refractory Inflammatory Bowel Disease: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
The Department of Gastroenterology plans to conduct a randomized controlled study on the efficacy analysis of hyperbaric oxygen-assisted treatment for acute severe ulcerative colitis and refractory inflammatory bowel disease. The research design is a randomized, controlled study. The objective is to compare the clinical remission rate, clinical response rate, endoscopic remission rate, and endoscopic response rate between patients with acute severe ulcerative colitis (ASUC) and refractory inflammatory bowel disease (IBD) treated with hyperbaric oxygen therapy (HBOT) as an adjuvant and those treated with standard treatment regimens. This study aims to provide clear evidence for the use of HBOT as an adjuvant treatment for ASUC and refractory IBD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the diagnostic criteria for ulcerative colitis in the 2018 national consensus opinion on the diagnosis and treatment of inflammatory bowel disease, it was confirmed as ulcerative colitis;
- •According to the Truelove-witts standard, it was diagnosed as acute severe ulcerative colitis: the frequency of bloody stools per day is 6 times or more, and at the same time, one of the following systemic toxic manifestations is present: heart rate of 90 bpm, body temperature greater than 37.8℃, hemoglobin less than 105g/L, and erythrocyte sedimentation rate greater than 30mm/h;
- •Age ≥ 18 years old;
- •Patients who can and are willing to comply with the research protocol can provide a signed and dated written informed consent form.
排除标准
- •Patients who may require immediate surgical treatment;
- •Pregnant or lactating mothers;
- •Patients with a score of ≥6 years old (TMM30/40/50) and <6 points in the measurement of the Eustachian tube;
- •Patients with a lung bulla larger than 2 cm at the lung apex or near the pleura in the chest plain scan;
- •Patients with severe liver or kidney dysfunction, heart failure or other serious systemic diseases;
- •Any situation that hinders the completion of the study or interferes with the analysis of the research results, including a history of drug or alcohol abuse, a smoker who has not quit, patients with mental illness or poor compliance, those with clear immune system (including HIV infection), blood system or tumor-related diseases;
- •Patients who have withdrawn their informed consent;
- •Patients who have participated in other clinical trials within 3 months before screening.
研究组 & 干预措施
Heperbaric oxygen-assisted Treatment
During the 7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day, hyperbaric oxygen therapy was also provided. The procedure was as follows:
- Pressurization: It took 25 minutes to increase the pressure from 1ATA to 2.5ATA (without oxygen inhalation)
- Stabilization: A total of 80 minutes (30 minutes of oxygen inhalation, 5 minutes of rest, 30 minutes of oxygen inhalation, 5 minutes of rest, 10 minutes of oxygen inhalation)
- Decompression: 25 minutes (the first 18 minutes continued oxygen inhalation, and then 7 minutes of oxygen inhalation was stopped)
干预措施: Administration of methylprednisolone sodium succinate (Drug)
Heperbaric oxygen-assisted Treatment
During the 7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day, hyperbaric oxygen therapy was also provided. The procedure was as follows:
- Pressurization: It took 25 minutes to increase the pressure from 1ATA to 2.5ATA (without oxygen inhalation)
- Stabilization: A total of 80 minutes (30 minutes of oxygen inhalation, 5 minutes of rest, 30 minutes of oxygen inhalation, 5 minutes of rest, 10 minutes of oxygen inhalation)
- Decompression: 25 minutes (the first 18 minutes continued oxygen inhalation, and then 7 minutes of oxygen inhalation was stopped)
干预措施: Hyperbaric Oxygen Therapy (Procedure)
Control Treatment
the 7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
干预措施: Administration of methylprednisolone sodium succinate (Drug)
结局指标
主要结局
Clinical response
时间窗: 7 days after treatment starts
The Mayo score (or partial Mayo score) decreased by at least 3 points or more compared to the baseline (before treatment), or decreased by at least 30% from the baseline level. The single-item bleeding score decreased by at least 1 point and the absolute score was ≤ 1.
次要结局
- Clinical remission(7 days after treatment starts)
- Endoscopic response(7 days after treatment starts)
- Endoscopic remission(7 days after treatment starts)
研究者
Jie Liang
Professor
Xijing Hospital of Digestive Diseases