Overview

Hyperbaric Oxygen Treatment in Humans With Gram Positive Cocci Endocarditis

Status:
Recruiting

Trial end date:
2021-12-31

Target enrollment:
0

Participant gender:
All

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 6-700 new cases annually. Approximately 45% of the patients must undergo cardiac surgery with replacement of infected cardiac valves by prosthetic valves. Recently, the formation of biofilms infections has drawn attention with respect to the effects of hyperbaric re-oxygenation of stricken tissues as anaerobic bacterial metabolism with low levels of activity within the biofilm environment, may be responsible for the development of antimicrobial resistance. Polymorphonuclear leukocytes (PMNs) consume available oxygen in the conversion of oxygen to ROS and in the formation of reactive nitrogen species (RNS) by inducible nitric oxide (iNOS) as PMN's are activated by bacteria. In pre-clinical context the effect of hyperbaric oxygen treatment (HBOT) in re-oxygenating biofilm related infections have been demonstrated in infected lungs with Pseudomonas aeruginosa and staphylococcus aureus endocarditis. Adjunctive HBOT has never been offered to patients with IE. However, HBOT may be associated with reduced compliance and side effects, such as equalisation problems of ears and sinuses and confinement anxiety, and the treatment is organizational challenging. On this basis the investigators suggest an initial feasibility study as the basis for a later and larger scaled randomized controlled trial of HBOT in patients with IE.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ole Hyldegaard

Collaborators:

Herlev Hospital
Rigshospitalet, Denmark

Criteria

Inclusion Criteria:

1. Left sided IE with gram positive cocci.

2. IE has been diagnosed according to modified Duke Criteria.

3. Patients must be stable, by means of no need for hemodynamic pressure support.

4. The patient must be able to be seated for the 1.5 hour the HBOT at least two times a
day for 3 days.

5. 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.

6. The upstart of HBOT must be within the first 2 weeks of relevant antibiotic IE
therapy.

7. If a central venous catheter has been inserted, a chest X-ray must confirm no
suspicion of pneumothorax.

8. Patients must be >18-years old.

Exclusion Criteria:

1. Claustrophobia that cannot be reversed by mild sedatives.

2. Patients requiring mechanical ventilation.

3. Undrained pneumothorax

4. Pregnancy

5. Unable to follow and understand simple commands

6. Non-compliant