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

Primary Purpose

Shock, Hypotension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PoCUS Guided Resuscitation of Shock
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring Ultrasonography, Point-of-care ultrasound, Resuscitation, Critical Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Science Center - Critical Care Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PoCUS Guided Resuscitation of Shock

Usual Care

Arm Description

Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.

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

Outcomes

Primary Outcome Measures

Recruitment rate
Number of patients who were successfully enrolled in the study per given week.

Secondary Outcome Measures

Mortality
proportion of patients who are deceased for any reason at 28 days
Successful randomization rate
proportion of eligible patients who were randomized within the window for enrolment
Protocol adherence rate
Proportion of participants in the intervention arm that received the intended intervention
Contamination rate
Proportion of participants who were randomized to the control arm and inadvertently received the intervention
Revoked deferred consent rate
Proportion of participants whose consent was revoked
ICU length of stay
total days spent in ICU from time of admission to time of patient discharge
Ventilator free days
Days alive and free of mechanical ventilation at 28 days
Continuous renal replacement therapy free days
Days alive and free of vasoactive medications at 28 days
Vasoactive medication free days
Days alive and free of vasoactive medications at 28 days
Cumulative fluid balance
Fluid balance at 7 days post ICU admission or at time of discharge
Acute Kidney Injury (AKIN) stage
AKIN stage at 7 days post ICU admission or at time of discharge

Full Information

First Posted
September 25, 2017
Last Updated
December 16, 2020
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03296891
Brief Title
Point of Care Ultrasonography In The Management of Shock: A Pilot Study
Official Title
Randomized Point of Care Ultrasound Guided Resuscitation and Usual Care Comparison in the Management of Undifferentiated Shock: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
November 7, 2020 (Actual)
Study Completion Date
November 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Hypotension
Keywords
Ultrasonography, Point-of-care ultrasound, Resuscitation, Critical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PoCUS Guided Resuscitation of Shock
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
PoCUS Guided Resuscitation of Shock
Intervention Description
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).
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Number of patients who were successfully enrolled in the study per given week.
Time Frame
averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)
Secondary Outcome Measure Information:
Title
Mortality
Description
proportion of patients who are deceased for any reason at 28 days
Time Frame
28 days
Title
Successful randomization rate
Description
proportion of eligible patients who were randomized within the window for enrolment
Time Frame
28 days
Title
Protocol adherence rate
Description
Proportion of participants in the intervention arm that received the intended intervention
Time Frame
28 days
Title
Contamination rate
Description
Proportion of participants who were randomized to the control arm and inadvertently received the intervention
Time Frame
28 days
Title
Revoked deferred consent rate
Description
Proportion of participants whose consent was revoked
Time Frame
28 days
Title
ICU length of stay
Description
total days spent in ICU from time of admission to time of patient discharge
Time Frame
28 days
Title
Ventilator free days
Description
Days alive and free of mechanical ventilation at 28 days
Time Frame
28 days
Title
Continuous renal replacement therapy free days
Description
Days alive and free of vasoactive medications at 28 days
Time Frame
28 days
Title
Vasoactive medication free days
Description
Days alive and free of vasoactive medications at 28 days
Time Frame
28 days
Title
Cumulative fluid balance
Description
Fluid balance at 7 days post ICU admission or at time of discharge
Time Frame
7 days
Title
Acute Kidney Injury (AKIN) stage
Description
AKIN stage at 7 days post ICU admission or at time of discharge
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
London Health Science Center - Critical Care Trauma Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.

Learn more about this trial

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

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