The Efficacy of Hyperbaric Oxygen-assisted Treatment for ASUC and Refractory IBD

Официальное название

Analysis of the Efficacy of Hyperbaric Oxygen-assisted Treatment for Acute Severe Ulcerative Colitis and Refractory Inflammatory Bowel Disease: A Randomized Controlled Study

Обзор

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.

Вмешательства

• Препарат Administration of methylprednisolone sodium succinate
  7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
• Процедура Hyperbaric Oxygen Therapy
  1. Pressurization: It took 25 minutes to increase the pressure from 1ATA to 2.5ATA (without oxygen inhalation) 2. 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) 3. Decompression: 25 minutes (the first 18 minutes continued oxygen inhalation, and then 7 minutes of oxygen inhalation was stopped)

Первичные конечные точки

• Clinical response [Срок оценки: 7 days after treatment starts]

Вторичные конечные точки (3)

• Clinical remission [Срок оценки: 7 days after treatment starts]
• Endoscopic response [Срок оценки: 7 days after treatment starts]
• Endoscopic remission [Срок оценки: 7 days after treatment starts]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xijing hospital of digestive diseases — Сиань

Публикации

• Singh AK, Jha DK, Jena A, Kumar-M P, Sebastian S, Sharma V. Hyperbaric oxygen therapy in inflammatory bowel disease: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e564-e573. doi: 10.1097/MEG.0000000000002164. PMID 33905214
• Glover LE, Colgan SP. Hypoxia and metabolic factors that influence inflammatory bowel disease pathogenesis. Gastroenterology. 2011 May;140(6):1748-55. doi: 10.1053/j.gastro.2011.01.056. PMID 21530741
• Yamashita M, Yamashita M. Hyperbaric oxygen treatment attenuates cytokine induction after massive hemorrhage. Am J Physiol Endocrinol Metab. 2000 May;278(5):E811-6. doi: 10.1152/ajpendo.2000.278.5.E811. PMID 10780936
• Wang Y, Chen D, Chen G. Hyperbaric oxygen therapy applied research in traumatic brain injury: from mechanisms to clinical investigation. Med Gas Res. 2014 Dec 4;4:18. doi: 10.1186/2045-9912-4-18. eCollection 2014. PMID 25905012
• Memar MY, Yekani M, Alizadeh N, Baghi HB. Hyperbaric oxygen therapy: Antimicrobial mechanisms and clinical application for infections. Biomed Pharmacother. 2019 Jan;109:440-447. doi: 10.1016/j.biopha.2018.10.142. Epub 2018 Nov 3. PMID 30399579
• Chen L, Wang Y, Zhou H, Liang Y, Zhu F, Zhou G. The new insights of hyperbaric oxygen therapy: focus on inflammatory bowel disease. Precis Clin Med. 2024 Jan 18;7(1):pbae001. doi: 10.1093/pcmedi/pbae001. eCollection 2024 Mar. PMID 38344218
• Parigi TL, D'Amico F, Abreu MT, Dignass A, Dotan I, Magro F, Griffiths AM, Jairath V, Iacucci M, Mantzaris GJ, O'Morain C, Reinisch W, Sachar DB, Turner D, Yamamoto T, Rubin DT, Peyrin-Biroulet L, Ghosh S, Danese S. Difficult-to-treat inflammatory bowel disease: results from an international consensus meeting. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):853-859. doi: 10.1016/S2468-1253(23)00154-1. PMID 37423233
• De Cristofaro E, Salvatori S, Marafini I, Zorzi F, Alfieri N, Musumeci M, Calabrese E, Monteleone G. Long-Term Risk of Colectomy in Patients with Severe Ulcerative Colitis Responding to Intravenous Corticosteroids or Infliximab. J Clin Med. 2022 Mar 18;11(6):1679. doi: 10.3390/jcm11061679. PMID 35330005

Идентификаторы

NCT: NCT07257588 · XJS20242001-C-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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