Remote monitoring of patients at risk of sepsis (REACT) - pilot
Research type
Research Study
Full title
Remote monitoring of cancer patients at risk of sepsis, a pilot study of using wearable biosensors in patients at high risk of chemotherapy associated neutropenic sepsis.
IRAS ID
271886
Contact name
John Radford
Contact email
Sponsor organisation
The Christie NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
Research Summary:
Chemotherapy is used to treat cancer in many thousands of patients per annum in the UK and millions worldwide. Most chemotherapy suppresses bone marrow function and causes a low white cell count (neutropenia) which is a major cause of sepsis, a potentially fatal medical emergency. Best outcomes in sepsis result from early admission to hospital with the rapid start of antibiotics and supportive care. Currently, patients starting chemotherapy are told the importance of making contact with the hospital if they feel unwell or develop a high temperature. Despite this it is common for patients to delay telephoning the Cancer Centre "hot line" until after enduring many hours of symptoms and ultimately being admitted to hospital very unwell and sometimes in life threatening septic shock.
This proposal (REACT) seeks to invert the current model of care with the aim of improving patient outcomes whilst reducing costs. In this proof of concept pilot study we aim to assess the feasibility of using remote wearable biosensors to record key physiological parameters (including respiratory rate, heart rate and temperature) and transmit this data centrally to The Christie. We will also assess retrospectively whether perturbations in biosensor collected data correlate with clinical episodes of sepsis and if so develop bespoke clinical algorithms to identify patients displaying “red flags” for sepsis and guide response. Data collected by the sensors is at this stage only being reviewed retrospectively.
Subsequent phases would involve recruiting larger number of patients to develop and test these algorithms with patients exhibiting ‘red flags’ for sepsis being contacted by the clinical team and taking appropriate action to facilitate assessment and treatment. The results of this study will determine whether working towards a randomised phase III trial comparing REACT with standard of care is an appropriate next step.Summary of Results:
The study did not open.
REACT was planned and given REC and HRA approval prior to the COVID-19 pandemic. In response to the pandemic, Professor Radford and team rapidly changed direction and conducted the RECAP study (IRAS ID 282489; REC reference 20/EE/0114), which utilised the remote monitoring technology to aid the management of cancer patients with symptoms suggestive of COVID-19. RECAP - Remote monitoring of Cancer Patients With Suspected Covid-19 [COVID-19] - Health Research Authority The remote monitoring technology landscape has changed in the years since REACT was designed and approved. As a result, Professor Radford has decided to close this protocol without opening to recruitment.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0080
Date of REC Opinion
29 Apr 2020
REC opinion
Further Information Favourable Opinion