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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Surrogate of Adequate Perfusion: Bladder Tissue Oxygen Monitoring

Clinicaltrials.gov identifier NCT03935477

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted May 2, 2019

Study Description

Brief summary:

The extent and duration of tissue hypoxia is a major determinant of outcome following major, high-risk surgery and in critical illness. Prompt restoration of tissue oxygenation through resuscitation in all likelihood improves outcomes. There are currently no bedside monitors in clinical practice that track tissue perfusion per se, instead clinicians rely on crude surrogates such as heart rate and blood pressure, urine output, serum lactate of global flow (cardiac output) monitoring. This is a first-in-man trial of a new device to measure tissue oxygenation in real time in a major, high-risk surgical and critical care cohort. The device consists of an oxygen sensing probe incorporated into a modified urinary catheter, which relies on photoluminescence technology and the quenching properties of oxygen. Once inserted, the drained bladder collapses round and envelopes the probe which continuously measures tissue oxygenation of the bladder urothelium. The investigators hope to (i) Establish that tissue oxygenation can be safely monitored using this technology, deployed in this way. (ii) Define a normal range for bladder tissue oxygenation in man as measured using this device. (iii) Compare tissue oxygenation against other markers of perfusion status in current clinical practice and assess its performance at detecting inadequate perfusion against these other modalities. (iv) assess the diagnostic and prognostic capabilities of the tissue oxygenation monitoring at detecting hypo-perfusion and predicting outcome. (v) Further assess the tissue response to an 'oxygen challenge' in identifying occult hypo-perfusion. (vi). Provide pilot work required to inform future, interventional studies where similar patients would be resuscitated to tissue oxygenation targets alongside routine clinical practice.

  • Condition or Disease:Surgery
    Shock
    Sepsis
  • Intervention/Treatment: Device: WellBeing catheter
  • Phase: N/A
Detailed Description

As above

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 315 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: An Observational Study of Tissue Oxygen Monitoring for Detecting Impending Shock States in the Critically Ill and Those Undergoing High Risk Surgery
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: March 2020
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Critical Care
Emergency admissions to UCLH critical care unit receiving arterial cannulation and urethral catheterisation as standard
Device: WellBeing catheter
Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension
: High risk surgery
those undergoing elective and emergency, high-risk surgery receiving arterial cannulation and urethral catheterisation as standard
Device: WellBeing catheter
Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension
Outcome Measures
  • Primary Outcome Measures: 1. Time to identification of a low bladder tissue PO2 versus time to development of hyperlactatemia (2 mmol/l) [ Time Frame: Up to 7 days ]
    Comparison of bladder tissue PO2 values (normal range to be defined as part of this first-in-man study) against lactate values >2 mmol/l
  • 2. Time to identification of a low bladder tissue PO2 versus time to development of hypotension (mean BP <60 mmHg) [ Time Frame: Up to 7 days ]
    Comparison of bladder tissue PO2 values (normal range to be defined as part of this first-in-man study) against mean BP values <60 mmHg
  • Secondary Outcome Measures: 1. Number of Participants With Device-Related Adverse Events [ Time Frame: Up to 28 days ]
    Monitoring of direct device-related complications (e.g. bleeding, bladder perforation)
  • 2. Identification of future complications in postoperative patients [ Time Frame: Up to 7 days ]
    Low bladder tissue PO2 values identify postoperative complications using POMS-score-defined morbidity at Days 3 and 7
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: as described above
Criteria

Inclusion Criteria:

- having major elective or emergency surgery (deemed to need invasive BP monitoring by
anaesthetist) and a urinary catheter

- OR emergency admission to critical care (necessitating arterial line and urinary
catheter).

Exclusion Criteria:

- age <18 - pregnancy - contraindication to arterial cannulation or urethral catheterisation - surgery on lower urinary tract/bladder - patient refusal

Contacts and Locations
Contacts

Contact: Mervyn Singer, MB BS +44-207-679-6714 m.singer@ucl.ac.uk

Contact: David Brealey, MB BS d.brealey@nhs.net

Locations

United Kingdom
UCL Hospitals NHS Foundation Trust
London

Sponsors and Collaborators

University College London Hospitals

Wellcome Trust

Department of Health, United Kingdom

Investigators

Principal Investigator: Mervyn Singer, MD UCL

More Information
  • Responsible Party: University College London Hospitals
  • ClinicalTrials.gov Identifier: NCT03935477 History of Changes
  • Other Study ID Numbers: CIP_DPW016_OBS
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: May 2, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Shock