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Clinical Trials/NCT03296891
NCT03296891
Completed
Not Applicable

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

Western University, Canada1 site in 1 country50 target enrollmentSeptember 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shock
Sponsor
Western University, Canada
Enrollment
50
Locations
1
Primary Endpoint
Recruitment rate
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 10, 2017
End Date
November 7, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Western University, Canada
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • Revoked deferred consent rate(28 days)
  • Cumulative fluid balance(7 days)
  • Protocol adherence rate(28 days)
  • Vasoactive medication free days(28 days)
  • Contamination rate(28 days)
  • Ventilator free days(28 days)
  • Acute Kidney Injury (AKIN) stage(7 days)
  • Mortality(28 days)
  • Successful randomization rate(28 days)
  • ICU length of stay(28 days)
  • Continuous renal replacement therapy free days(28 days)

Study Sites (1)

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