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Completed

NCT Number: NCT03296891

Point of Care Ultrasonography In The Management of 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).

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Key information

Conditions

Shock Cardiovascular Diseases Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Science Center - Critical Care Trauma Center

London, Ontario, N6A5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Recruitment rate

    Time frame: 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 outcomes

  1. Mortality

    Time frame: 28 days

    proportion of patients who are deceased for any reason at 28 days

  2. Successful randomization rate

    Time frame: 28 days

    proportion of eligible patients who were randomized within the window for enrolment

  3. Protocol adherence rate

    Time frame: 28 days

    Proportion of participants in the intervention arm that received the intended intervention

  4. Contamination rate

    Time frame: 28 days

    Proportion of participants who were randomized to the control arm and inadvertently received the intervention

  5. Revoked deferred consent rate

    Time frame: 28 days

    Proportion of participants whose consent was revoked

  6. ICU length of stay

    Time frame: 28 days

    total days spent in ICU from time of admission to time of patient discharge

  7. Ventilator free days

    Time frame: 28 days

    Days alive and free of mechanical ventilation at 28 days

  8. Continuous renal replacement therapy free days

    Time frame: 28 days

    Days alive and free of vasoactive medications at 28 days

  9. Vasoactive medication free days

    Time frame: 28 days

    Days alive and free of vasoactive medications at 28 days

  10. Cumulative fluid balance

    Time frame: 7 days

    Fluid balance at 7 days post ICU admission or at time of discharge

  11. Acute Kidney Injury (AKIN) stage

    Time frame: 7 days

    AKIN stage at 7 days post ICU admission or at time of discharge

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2017
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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