Hypotension, Shock
Conditions
Keywords
Ultrasonography, Point-of-care ultrasound, Resuscitation, Critical Care
Brief 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).
Interventions
OTHERPoCUS Guided Resuscitation of Shock
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).
Sponsors
Western University, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the following: 1. Lactate greater than or equal to 2.2 mmol/L 2. AKIN stage I or greater or Urine output less than 0.5 cc/hr 3. Altered level of consciousness due to shock or requiring invasive mechanical ventilation as a result of shock 4. Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.
Exclusion criteria
1. Pregnant patients 2. Participants who have already undergone a PoCUS study (as defined in the protocol for this study) within the past 48 hours 3. Participants who have restrictions on their goals of care at the time of ICU admission (including patients refusing blood products). 4. Patients post cardiac arrest who are not obeying commands
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful randomization rate | 28 days | proportion of eligible patients who were randomized within the window for enrolment |
| Protocol adherence rate | 28 days | Proportion of participants in the intervention arm that received the intended intervention |
| Contamination rate | 28 days | Proportion of participants who were randomized to the control arm and inadvertently received the intervention |
| Revoked deferred consent rate | 28 days | Proportion of participants whose consent was revoked |
| ICU length of stay | 28 days | total days spent in ICU from time of admission to time of patient discharge |
| Mortality | 28 days | proportion of patients who are deceased for any reason at 28 days |
| Continuous renal replacement therapy free days | 28 days | Days alive and free of vasoactive medications at 28 days |
| Vasoactive medication free days | 28 days | Days alive and free of vasoactive medications at 28 days |
| Cumulative fluid balance | 7 days | Fluid balance at 7 days post ICU admission or at time of discharge |
| Acute Kidney Injury (AKIN) stage | 7 days | AKIN stage at 7 days post ICU admission or at time of discharge |
| Ventilator free days | 28 days | Days alive and free of mechanical ventilation at 28 days |
Countries
Canada
Outcome results
None listed