Trial of Hyperoxic O2 Therapy vs. Normoxic O2 Therapy in Sepsis

• Status: Completed
• Trial end date: 2016-11-10
• Target enrollment: 0
• Participant gender: All

Summary

The motivation for this study comes from a desire to improve the mortality of patients with sepsis. Oxygen is cheap, readily available and is included in current United Kingdom Emergency Department guidelines, but it may also be harmful to patients with sepsis - it is important to know if this is the case.

This study is a pilot study to also assess the feasibility of delivering a larger adequately powered study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Plymouth Hospitals NHS Trust; University Hospital Plymouth NHS Trust

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.

Exclusion Criteria:

• Female participants who are pregnant

• Existing diagnosis of chronic obstructive pulmonary disease (COPD)

• A primary diagnosis (or suspected diagnosis) of:

• an acute cerebral vascular event

• acute coronary syndrome

• acute pulmonary oedema

• status asthmatic

• major cardiac arrhythmia (as part of primary diagnosis)

• seizure

• drug overdose

• injury 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).