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

NCT02378545 | Completed Phase 4

• 2 other identifiers: 15/P/0202015-000629-35
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

Sepsis; Hyperoxia; Sepsis Six; Oxygen delivery

Outcome Measures

Primary Outcomes (1)

• Does delivery of high flow oxygen (hyperoxic oxygen therapy) compared to titrated oxygen therapy (normoxic oxygen therapy) reduce mortality at 90 days

  Adult patients with sepsis presenting to the emergency department by ambulance.

  90 days

Study Arms (2)

Hyperoxia

ACTIVE COMPARATOR

Oxygen will be administered using a non-re-breathe oxygen mask applied over the face and nose. The oxygen delivery device will be set to deliver oxygen at 15 litres per minute. The oxygen will be continuously delivered throughout the patients stay in the Emergency Department.

Drug: Oxygen

normoxia

ACTIVE COMPARATOR

Oxygen will not be administered if a patient's oxygen saturations (as measured using a pulse oximeter) are less than 94%. If a patient's oxygen saturations are less than 94%, oxygen will be 'titrated' using a 'venturi' type oxygen delivery device to achieve target saturations of 94%. Following initial dynamic titration (to identify correct oxygen delivery level) the oxygen delivery device will be re-evaluated hourly during the patient's stay in the emergency department.

Drug: Oxygen

Interventions

Oxygen DRUG

On the Hyperoxia arm: Oxygen will be administered using a non-re-breathe oxygen mask applied over the face and nose. On the Normoxia arm: In many cases oxygen will not be administered. If required the minimum percentage required to reach the target saturations will be administered. In a majority of cases this will be via a venturi mask.

Also known as: Medical Oxygen

Hyperoxia; normoxia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

MeSH Terms

Conditions

Sepsis; Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Tim Nutbeam, MBBS

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 4, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 10, 2016
• Last Updated: September 19, 2017

Record last verified: 2016-10

Locations

GB (1)