FEASIBILITY, OPEN LABEL, RANDOMISED CONTROLLED TRIAL OF HYPEROXIC O2 THERAPY VS. NORMOXIC O2 THERAPY IN SEPSIS

Phase 1

• Conditions: MedDRA version: 18.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; sepsis

• Registration Number: EUCTR2015-000629-35-GB
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-13
• Study Completion: 2016-11-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria
•Adult patients aged 18 years or above.
•Diagnosed with presumed ‘Sepsis’
•Arrive at Derriford Emergency Department by ambulance.
•Provision of informed consent.
•Willing to allow their General Practitioner and consultant, if appropriate,to be notified of participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
•Female participants who are pregnant
•Existing diagnosis of chronic obstructive pulmonary disease (COPD)
•A primary diagnosis (or suspected diagnosis) of:
oan acute cerebral vascular event
oacute coronary syndrome
oacute pulmonary oedema
ostatus asthmaticus
omajor cardiac arrhythmia (as part of primary diagnosis)
oseizure
odrug overdose
oinjury from burn or trauma
•Participants who require immediate intubation and ventilation on arrival in the Emergency Department
•Participants undergoing or have undergone cardiopulmonary resuscitation in the pre-hospital phase of their treatment.
•Current participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified