Point of Care Ultrasonography In The Management of Shock: A Pilot Study

Study Overview
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Brief Summary
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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).

Official Title
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Randomized Point of Care Ultrasound Guided Resuscitation and Usual Care Comparison in the Management of Undifferentiated Shock: a Pilot Study

Conditions
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Shock, Hypotension

Intervention / Treatment
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* Other: PoCUS Guided Resuscitation of Shock


Participation Criteria
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Eligibility Criteria
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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: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PoCUS Guided Resuscitation of Shock<br>Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock. | Other: PoCUS Guided Resuscitation of Shock<br>* 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).<br>|
| No Intervention: Usual Care<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasonography, Point-of-care ultrasound, Resuscitation, Critical Care