Status:
UNKNOWN
Hyperbaric Oxygen Treatment in Humans With Gram Positive Cocci Endocarditis
Lead Sponsor:
Ole Hyldegaard
Collaborating Sponsors:
Rigshospitalet, Denmark
Herlev Hospital
Conditions:
Infectious Endocarditis
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
Brief Summary
Infectious endocarditis (IE) is defined as an infection anywhere on the endocardium, most often localised to the cardiac valves. It is an infection with an increasing incidence and in Denmark with 6-7...
Detailed Description
During antibiotic treatments with the indicated antibiotics the susceptible bacteria are subjected to metabolic changes of the Krebs cycles leading to intrabacterial accumulation of toxic hydroxyl oxy...
Eligibility Criteria
Inclusion
- Left sided IE with gram positive cocci.
- IE has been diagnosed according to modified Duke Criteria.
- Patients must be stable, by means of no need for hemodynamic pressure support.
- The patient must be able to be seated for the 1.5 hour the HBOT at least two times a day for 3 days.
- The patient must be able to perform Valsalva's - or Frenzels manoeuvre - to equalize middle ear pressure. As prophylaxis, all patients will receive detumescent nose drops as Otrivin® to facilitate ear- and sinuses equilibration. In the rare event it is still not possible for the patient to equalize pressure, a paracentesis or drainage of the tympanic membrane must be performed by the ear-nose and throat (ENT) doctor. All according to daily practice.
- The upstart of HBOT must be within the first 2 weeks of relevant antibiotic IE therapy.
- If a central venous catheter has been inserted, a chest X-ray must confirm no suspicion of pneumothorax.
- Patients must be \>18-years old.
Exclusion
- Claustrophobia that cannot be reversed by mild sedatives.
- Patients requiring mechanical ventilation.
- Undrained pneumothorax
- Pregnancy
- Unable to follow and understand simple commands
- Non-compliant
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04691440
Start Date
December 1 2019
End Date
December 31 2021
Last Update
December 31 2020
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100