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slow recruitment
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of Pittsburgh | OTHER |
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The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | patients will undergo daily hyperbaric oxygen sessions in addition to IV steroids for 10 days. |
|
| Sham | Sham Comparator | Patients will undergo sham hyperbaric air sessions in addition to IV steroids for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen | Procedure | patients will be placed in a monoplane chamber and pressurized to 2.4 atmospheres with 100% oxygen for 90 minutes per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Response | Impact of hyperbaric oxygen therapy on clinical response/remission to medical therapy as measured by the partial Mayo score at study day 5. Clinical remission will be defined as a partial Mayo score of less than or equal to 2 with no individual sub-score exceeding 1 point. Clinical response will be defined as a decrease in partial Mayo score greater than or equal to 2 points with a decrease in rectal bleeding sub-score of greater than or equal to 1 point, or an absolute rectal bleeding sub-score of 0 or 1. | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Full Mayo Score | We will compare the % and absolute reduction in the full Mayo score at study day 10 between the intervention and sham control group | Day 10 |
| Reduction in Inflammatory Markers |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperbaric Oxygen Safety | The rate of barotrauma, seizures, or claustrophobia with hyperbaric oxygen therapy will be monitored to ensure there are no safety concerns with this intervention. Patients will be assessed before and after each treatment session for any complications related to hyperbaric oxygen therapy. This will be done daily until all 10 treatments are completed. | before and after hyperbaric oxygen treatments |
Inclusion Criteria:
Exclusion Criteria:
Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to:
Neurological and Psychological i. Vagal or other nerve stimulators
ii. Uncontrolled seizure disorder
iii. Medications or medical conditions that lower seizure threshold (in the opinion of the investigator) iv. Drug or alcohol abuse/dependence v. Current treatment for alcohol cessation with disulfiram vi. Current or recent (within past week) use of baclofen Head and Neck i. Previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (in the opinion of the investigator) ii. Current or previous retinal detachment or optic neuritis iii. Retinal or vitreous surgery within the past 3 months Miscellaneous i. Implanted devices not on the approved list for use with HBOT
Women who are pregnant or nursing. Women with childbearing potential were required to use effective birth control if not surgically sterile or postmenopausal for >2 years.
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| Name | Affiliation | Role |
|---|---|---|
| Corey A Siegel, MD, MS | Dartmouth-Hitchcock Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Dartmouth-Hitchcock Medical Center |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| Sham Hyperbaric Air | Procedure | Patients will undergo a brief compression to 1.34 atmospheres with room air and then they will be brought back to 1.1 atmospheres to complete a 90 minute session. |
|
We will compare the % and absolute reduction in the CRP and ESR at study days 3, 5 and 10 between the intervention and sham control group
| Day 10 |
| Progression to Second Line Therapy | We will compare the proportion of patients requiring infliximab, cyclosporine or colectomy during hospitalization between the intervention and sham control group | Day 10 |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |