ShockNCT03296891
Point of Care Ultrasonography In The Management of Shock: A Pilot Study
A study testing PoCUS Guided Resuscitation of Shock in people with Shock and Hypotension, run by Western University, Canada at 1 site in Canada.
Trial summary
This project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre (LHSC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Hypotension
- What is being tested?
- PoCUS Guided Resuscitation of Shock
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2017to 7 Nov 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following:
- Lactate greater than or equal to 2.2 mmol/L
- AKIN stage I or greater or Urine output less than 0.5 cc/hr
- Altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock
- Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.
Who cannot join
- Pregnant patients
- Participants who have already undergone a PoCUS study (as defined in the protocol for this study) within the past 48 hours
- Participants who have restrictions on their goals of care at the time of ICU admission (including patients refusing blood products).
- Patients post cardiac arrest who are not obeying commands
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Science Center - Critical Care Trauma Center
London, Ontario, N6A5W9
About this study
Official title: Randomized Point of Care Ultrasound Guided Resuscitation and Usual Care Comparison in the Management of Undifferentiated Shock: a Pilot Study
This project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre (LHSC).
- Conditions
- Shock, Hypotension
- Being tested
- PoCUS Guided Resuscitation of Shock
- Keywords
- Ultrasonography, Point-of-care ultrasound, Resuscitation, Critical Care
- Medical subject headings
- Shock, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PoCUS Guided Resuscitation of ShockOther
Point-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS).
| Study group | Role | What they receive |
|---|---|---|
| PoCUS Guided Resuscitation of Shock | Active comparator | Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock. Receives: Other: PoCUS Guided Resuscitation of Shock |
| Usual Care | No intervention | Participants randomized to the 'usual care' arm of the study will be suggested to have the following guide resuscitation: 1) Pulse pressure variation (PPV), stroke volume variation (SVV) and/or systolic pressure variation (SPV) on their arterial line, 2) central venous pressure (CVP) and oxygen saturation(ScvO2) measurement, 3) Passive leg raise (PLR) maneuver, and/or 4) pulmonary artery catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients who were successfully enrolled in the study per given week.
Measured: averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)
Secondary outcomes (11)
Mortality
proportion of patients who are deceased for any reason at 28 days
Measured: 28 days
Successful randomization rate
proportion of eligible patients who were randomized within the window for enrolment
Measured: 28 days
Protocol adherence rate
Proportion of participants in the intervention arm that received the intended intervention
Measured: 28 days
Contamination rate
Proportion of participants who were randomized to the control arm and inadvertently received the intervention
Measured: 28 days
Revoked deferred consent rate
Proportion of participants whose consent was revoked
Measured: 28 days
ICU length of stay
total days spent in ICU from time of admission to time of patient discharge
Measured: 28 days
Ventilator free days
Days alive and free of mechanical ventilation at 28 days
Measured: 28 days
Continuous renal replacement therapy free days
Days alive and free of vasoactive medications at 28 days
Measured: 28 days
Vasoactive medication free days
Days alive and free of vasoactive medications at 28 days
Measured: 28 days
Cumulative fluid balance
Fluid balance at 7 days post ICU admission or at time of discharge
Measured: 7 days
Acute Kidney Injury (AKIN) stage
AKIN stage at 7 days post ICU admission or at time of discharge
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start10 Sep 2017
- Primary completion7 Nov 2020
- Study completion7 Nov 2020
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.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296891
- Sponsor's protocol ID
- 109038
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Point of Care Ultrasound Guided Resuscitation and Usual Care Comparison in the Management of Undifferentiated Shock: a Pilot Study
- ClinicalTrials.gov ID
- NCT03296891
- Acronym / sponsor ID
- 109038
- Conditions
- Shock, Hypotension
- Keywords
- Ultrasonography, Point-of-care ultrasound, Resuscitation, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 7 Nov 2020 (actual)
- First posted
- 28 Sep 2017 (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.
This project aims to determine the feasibility of conducting a randomized controlled trial investigating point of care ultrasound guided resuscitation compared with usual care in the management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre (LHSC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PoCUS Guided Resuscitation of Shock | Active comparator | Other: PoCUS Guided Resuscitation of ShockParticipants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock. |
| Usual Care | No intervention | –Participants randomized to the 'usual care' arm of the study will be suggested to have the following guide resuscitation: 1) Pulse pressure variation (PPV), stroke volume variation (SVV) and/or systolic pressure variation (SPV) on their arterial line, 2) central venous pressure (CVP) and oxygen saturation(ScvO2) measurement, 3) Passive leg raise (PLR) maneuver, and/or 4) pulmonary artery catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following:
- Lactate greater than or equal to 2.2 mmol/L
- AKIN stage I or greater or Urine output less than 0.5 cc/hr
- Altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock
- Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.
Key exclusion criteria (4 listed)
- Pregnant patients
- Participants who have already undergone a PoCUS study (as defined in the protocol for this study) within the past 48 hours
- Participants who have restrictions on their goals of care at the time of ICU admission (including patients refusing blood products).
- Patients post cardiac arrest who are not obeying commands
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 |
|---|---|---|
| PoCUS Guided Resuscitation of ShockPoint-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS). | Other | PoCUS Guided Resuscitation of Shock |
Primary outcome
Recruitment rate
Time frame: averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)
Number of patients who were successfully enrolled in the study per given week.
11 secondary outcomes
Mortality
Time frame: 28 days
Successful randomization rate
Time frame: 28 days
Protocol adherence rate
Time frame: 28 days
Contamination rate
Time frame: 28 days
Revoked deferred consent rate
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Ventilator free days
Time frame: 28 days
Continuous renal replacement therapy free days
Time frame: 28 days
Vasoactive medication free days
Time frame: 28 days
Cumulative fluid balance
Time frame: 7 days
Acute Kidney Injury (AKIN) stage
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No. No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.
Related trials for Shock
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PoCUS Guided Resuscitation of Shock in people with Shock and Hypotension, run by Western University, Canada at 1 site in Canada.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2020. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)). 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 19 Dec 2020.