HO2T or NO2T Trial
Research type
Research Study
Full title
(Feasibility) Open label Randomised Controlled Trial of Hyperoxic O2 Therapy vs. Normoxic O2 Therapy in Sepsis
IRAS ID
171788
Contact name
Tim Nutbeam
Contact email
Eudract number
2015-000629-35
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Sepsis is a life threatening systemic inflammatory response to infection. It affects over 100,000 people each year in the UK and contributes to almost 37,000 deaths, costing the NHS an estimated £2.5 billion. The combination of an aging population, the emergence of drug resistant and more virulent microbes, and high risk surgical procedures means that sepsis is becoming more prevalent.1 Early management of sepsis using resuscitation bundles such as the ‘sepsis six’ (Box 1) is highly effective, demonstrating numbers needed to treat (NNT) as low as 4.6 when delivered within one hour of diagnosis (i.e. one death prevented for every 4.6 patients treated). This compares very favourably with other treatments delivered in the emergency setting (tranexamic acid in trauma, NNT=~67; aspirin in myocardial infarction, NNT=~42)2,3. The College of Emergency Medicine recommends that patients with sepsis should receive the Sepsis 6 within one hour of diagnosis in the ED, with regular reassessment and further action as required.
Box 1:Sepsis 6 resuscitation bundle
Actions to be achieved within 1 hour of identification of sepsis:
1 High-flow oxygen OR Titrated Oxygen Therapy (titrated for COPD)
2 Blood cultures and consider source control.
3 Intravenous antibiotics.
4 Intravenous fluid resuscitation.
5 Check haemoglobin and serial lactates.
6 Hourly urine output measurement.Currently there is no consensus on the use of oxygen therapy in sepsis resuscitation. Uncertainty exists as to whether increasing oxygen above physiological levels (hyperoxia) or maintaining physiological oxygen concentration (normoxia) confers the most benefit to patients. This study hopes to be able to indicate whether hyperoxia is beneficial or not, as well the study hopes to further increase the effectiveness of sepsis resuscitation.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
15/WM/0175
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion