ShockSoAP-BOxNCT03935477
Surrogate of Adequate Perfusion: Bladder Tissue Oxygen Monitoring
An observational study of Shock and Sepsis, run by University College London Hospitals at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- WellBeing catheter
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2019to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: as described above
Who may be able to join
- 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).
Who cannot join
- age <18
- pregnancy
- contraindication to arterial cannulation or urethral catheterisation
- surgery on lower urinary tract/bladder
- patient refusal
Trial locations and contacts
1 site in 1 country.
David Brealey, MB BS contact
United Kingdom1 site, 1 recruiting
- Recruiting
UCL Hospitals NHS Foundation Trust
London, NW1
Mervyn Singer, MD FRCP, +44 207 679 9666, m.singer@ucl.ac.uk
David Brealey, FRCA FFICM, +44 203 447 3363, d.brealey@nhs.net
About this study
Official title: An Observational Study of Tissue Oxygen Monitoring for Detecting Impending Shock States in the Critically Ill and Those Undergoing High Risk Surgery
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.
Read more
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.
Read the detailed description
As above
- Being tested
- WellBeing catheter
- Medical subject headings
- Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellBeing catheterDevice
Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension
| Study group | Role | What they receive |
|---|---|---|
| High risk surgery | those undergoing elective and emergency, high-risk surgery receiving arterial cannulation and urethral catheterisation as standard Receives: Device: WellBeing catheter | |
| Critical Care | Emergency admissions to UCLH critical care unit receiving arterial cannulation and urethral catheterisation as standard Receives: Device: WellBeing catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to identification of a low bladder tissue PO2 versus time to development of hyperlactatemia (2 mmol/l)
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
Measured: Up to 7 days
Time to identification of a low bladder tissue PO2 versus time to development of hypotension (mean BP <60 mmHg)
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
Measured: Up to 7 days
Secondary outcomes (2)
Number of Participants With Device-Related Adverse Events
Monitoring of direct device-related complications (e.g. bleeding, bladder perforation)
Measured: Up to 28 days
Identification of future complications in postoperative patients
Low bladder tissue PO2 values identify postoperative complications using POMS-score-defined morbidity at Days 3 and 7
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start10 Apr 2019
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Department of Health, United Kingdom
- Responsible party
- Principal investigator, Professor Mervyn Singer, University College London Hospitals
- Investigators
- Mervyn Singer, MD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935477
- Sponsor's protocol ID
- CIP_DPW016_OBS
- Acronym
- SoAP-BOx
- Status last verified
- May 2019
- First submitted
- 13 Mar 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Tissue Oxygen Monitoring for Detecting Impending Shock States in the Critically Ill and Those Undergoing High Risk Surgery
- ClinicalTrials.gov ID
- NCT03935477
- Acronym / sponsor ID
- SoAP-BOx / CIP_DPW016_OBS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- Wellcome Trust, Department of Health, United Kingdom
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk surgery | – | Device: WellBeing catheterthose undergoing elective and emergency, high-risk surgery receiving arterial cannulation and urethral catheterisation as standard |
| Critical Care | – | Device: WellBeing catheterEmergency admissions to UCLH critical care unit receiving arterial cannulation and urethral catheterisation as standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- as described above
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- age <18
- pregnancy
- contraindication to arterial cannulation or urethral catheterisation
- surgery on lower urinary tract/bladder
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WellBeing catheterUrethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension | Device | Critical Care, High risk surgery |
Primary outcome
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
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
2 secondary outcomes
Number of Participants With Device-Related Adverse Events
Time frame: Up to 28 days
Identification of future complications in postoperative patients
Time frame: Up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brealey, MB BS contact
Mervyn Singer, MD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Sepsis, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mervyn Singer, MB BS (+44-207-679-6714, m.singer@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to identification of a low bladder tissue PO2 versus time to development of hyperlactatemia (2 mmol/l) (time frame: Up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.