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Hyperbaric Oxygen for Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02144350
Recruitment Status : Terminated (slow recruitment)
First Posted : May 22, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
Mayo Clinic
University of Pittsburgh
Information provided by (Responsible Party):
Corey Siegel, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE May 22, 2014
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
Primary Response [ Time Frame: Day 5 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
  • Reduction in Full Mayo Score [ Time Frame: Day 10 ]
    We will compare the % and absolute reduction in the full Mayo score at study day 10 between the intervention and sham control group
  • Reduction in Inflammatory Markers [ Time Frame: Day 10 ]
    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
  • Progression to Second Line Therapy [ Time Frame: Day 10 ]
    We will compare the proportion of patients requiring infliximab, cyclosporine or colectomy during hospitalization between the intervention and sham control group
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 19, 2014)
Hyperbaric Oxygen Safety [ Time Frame: before and after hyperbaric oxygen treatments ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen for Ulcerative Colitis
Official Title  ICMJE Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Procedure: Hyperbaric oxygen
    patients will be placed in a monoplane chamber and pressurized to 2.4 atmospheres with 100% oxygen for 90 minutes per session.
  • Procedure: Sham Hyperbaric Air
    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.
Study Arms  ICMJE
  • Experimental: Intervention
    patients will undergo daily hyperbaric oxygen sessions in addition to IV steroids for 10 days.
    Intervention: Procedure: Hyperbaric oxygen
  • Sham Comparator: Sham
    Patients will undergo sham hyperbaric air sessions in addition to IV steroids for 10 days
    Intervention: Procedure: Sham Hyperbaric Air
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
18
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2014)
77
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • known or newly diagnosed moderate to severe ulcerative colitis with a Mayo score of greater than 6
  • Mayo endoscopic sub-score of greater than or equal to 2
  • Risk score of greater than or equal to 4 points

Exclusion Criteria:

  • Complication requiring urgent surgical intervention (in the opinion of the investigators)

Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to:

  • Pulmonary i. COPD with CO2 retention; Previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs (opinion of investigators) ii. Current pneumothorax or previous spontaneous pneumothorax iii. Bronchogenic cyst(s)
  • Cardiac i. Uncontrolled HTN (systolic >160 or diastolic >100) ii. Unstable angina or myocardial infarction within the previous 3 months iii. Ejection fraction < 35% iv. Current or previous amiodarone use v. ICD in place vi. Pacemaker in place not approved for chamber use
  • Hematological/Oncological i. Current chemotherapeutic drug use, and past history of bleomycin use. ii. Hereditary Spherocytosis iii. Sickle cell anemia
  • Gastrointestinal and Infectious Disease i. Known or suspected Crohn's disease ii. Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C iii. Gastrointestinal or systemic infection including, but not limited to, --Clostridium difficile iv. Current capsule endoscopy or previously non-retrieved capsule Endocrinology i. Uncontrolled hyperthyroidism

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02144350
Other Study ID Numbers  ICMJE Broad-IBD-0372
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Corey Siegel, Dartmouth-Hitchcock Medical Center
Original Responsible Party Dartmouth-Hitchcock Medical Center
Current Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Mayo Clinic
  • University of Pittsburgh
Investigators  ICMJE
Study Director: Corey A Siegel, MD, MS Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP