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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PoCUS Guided Resuscitation of Shock | Active Comparator | Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PoCUS Guided Resuscitation of Shock | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of patients who were successfully enrolled in the study per given week. | averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | proportion of patients who are deceased for any reason at 28 days | 28 days |
| Successful randomization rate | proportion of eligible patients who were randomized within the window for enrolment |
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Inclusion Criteria:
Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Center - Critical Care Trauma Center | London | Ontario | N6A5W9 | Canada |
No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.
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| ID | Term |
|---|---|
| D012769 | Shock |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 28 days |
| Protocol adherence rate | Proportion of participants in the intervention arm that received the intended intervention | 28 days |
| Contamination rate | Proportion of participants who were randomized to the control arm and inadvertently received the intervention | 28 days |
| Revoked deferred consent rate | Proportion of participants whose consent was revoked | 28 days |
| ICU length of stay | total days spent in ICU from time of admission to time of patient discharge | 28 days |
| Ventilator free days | Days alive and free of mechanical ventilation at 28 days | 28 days |
| Continuous renal replacement therapy free days | Days alive and free of vasoactive medications at 28 days | 28 days |
| Vasoactive medication free days | Days alive and free of vasoactive medications at 28 days | 28 days |
| Cumulative fluid balance | Fluid balance at 7 days post ICU admission or at time of discharge | 7 days |
| Acute Kidney Injury (AKIN) stage | AKIN stage at 7 days post ICU admission or at time of discharge | 7 days |