Bacterial Endocarditis MedDRA version: 20.0 Level: PT Classification code 10057480 Term: Hyperbaric oxygen therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Conoxia 100%
Pharmaceutical Form: Inhalation solution
Sponsors
Rigshospitalet - University Hospital of Copenhagen
Eligibility
Sex/Gender
All
Inclusion 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 ENT doctor. All according to daily practice. 6) The upstart of HBOT must be within the first week 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess feasibility including patient compliance of adding HyperBaric Oxygen Treatment (HBOT) to the standard management of patients with proven bacterial endocarditis.;Secondary Objective: Not applicable;Primary end point(s): Observations of interest / endpoints: 1) Patient baseline data 2) Patient compliance (tolerance/acceptance of the treatment – and number of the scheduled 6 treatments accepted by the patients) 3) Practical feasibility (are we capable of organising all 6 treatments for the individual patients according to the protocol) 4) Findings at echocardiography (TTE/TEE) within 48 h before HBOT and < 48 h after last HBOT 5) Daily blood samples with infection parameters: CRP, PCT, leukocyte + differential count, Hb 6) One blood sample for Biomarkers (10mL EDTA) 7) Blood cultures of patients daily 8) Blood sample for Dihydrorhodamin testing (DHR, functionality of the PMNs respiratory burst capacity) and fagocytosis test less than one hour before the first daily HBOT and right after. Likewise, for the coagulation status by means of TEG/rotem analysis. ;Timepoint(s) of evaluation of this end point: Patient endpoints at minimum 48 hours after last HBOT session during hospitalization and until discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Denmark
Contacts
Public ContactHyperbaric Unit sect.4092
Rigshospitalet - University Hospital of Copenhagen
Outcome results
None listed