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Remote Monitoring of Patients at Risk of Sepsis

NCT04260230 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-12-30

No results posted yet for this study

Summary

Chemotherapy is used to treat cancer in many thousands of patients per annum in the United Kingdom 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 the investigators 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. The investigators 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.

Conditions

Interventions

DEVICE

Lifetemp/Lifetouch sensors

Wearing the devices for six weeks. Data only reviewed retrospectively.

Sponsors & Collaborators

  • Isansys Lifecare LTD

    collaborator UNKNOWN

  • University of Manchester

    collaborator OTHER

  • The Christie NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-10-31
Completion
2024-12-19

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04260230 on ClinicalTrials.gov