FLO-ELA
Research type
Research Study
Full title
FLO-ELA: FLuid Optimisation in Emergency LAparotomy. Open, multi-centre, randomised controlled trial of cardiac output -guided haemodynamic therapy compared to usual care in patients undergoing emergency bowel surgery.
IRAS ID
214459
Contact name
Mark Edwards
Contact email
Sponsor organisation
University Hospital Southampton NHSFT
ISRCTN Number
ISRCTN14729158
Duration of Study in the UK
4 years, 8 months, 31 days
Research summary
We aim to trial a treatment used to guide the dose and timing of fluid administered into the bloodstream to patients during and shortly after surgery. We will trial this treatment, called “goal-directed haemodynamic therapy” (GDHT), in patients undergoing emergency bowel surgery (laparotomy).
Emergency laparotomy is a common major emergency surgical procedure, performed to treat life-threatening conditions caused by cancer, infections or previous surgery. Over 30,000 people in England & Wales undergo this surgery annually at a cost of over £650m. Outcomes from emergency bowel surgery are poor; 14% of patients aged over 50 die within a month of surgery, rising to 20% within three months. As this surgery is so common, treatments that reduce death rates even slightly could save hundreds of lives.
Major surgery and critical illness (both features of emergency bowel surgery) reduce blood flow to vital organs. This can cause serious complications and death after surgery. Fluids are given into the bloodstream to improve blood flow. Giving the right amount of fluid at the right time has a major impact on outcomes after surgery, but is hard to gauge accurately. Clinicians normally use signs such as heart rate and blood pressure to guide them, but these can be unreliable. GDHT aims to address this. It lets clinicians determine the dose and timing of fluid to give patients, guided by a monitor measuring the blood flow pumped by the heart. GDHT may be beneficial in planned surgery, but has not been properly tested in the complex setting of emergency bowel surgery.
We aim to determine whether GDHT given to patients aged 50+ during and for up to six hours after emergency laparotomy reduces the number of deaths within 90 days of surgery. We propose a multicentre clinical trial in 7646 patients recruited from 100 UK hospitals over three years.
REC name
London - Bromley Research Ethics Committee
REC reference
17/LO/0334
Date of REC Opinion
28 Mar 2017
REC opinion
Further Information Favourable Opinion