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

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).

Study Overview

• Status: Completed
• Conditions: Shock; Hypotension
• Intervention / Treatment: Other: PoCUS Guided Resuscitation of Shock

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5W9
      • London Health Science Center - Critical Care Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PoCUS Guided Resuscitation of Shock; Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.	Other: PoCUS 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).
No Intervention: Usual Care; 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?

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

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Actual): November 7, 2020
• Study Completion (Actual): November 7, 2020

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Point-of-care ultrasound; Ultrasonography; Critical Care; Resuscitation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Shock; Hypotension
• Other Study ID Numbers: 109038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No