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

Not Applicable

Completed

• Conditions: Shock; Hypotension
• Interventions: Other: PoCUS Guided Resuscitation of Shock

• Registration Number: NCT03296891
• Lead Sponsor: Western University, Canada

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-10
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-09-28
• Primary Completion: 2020-11-07
• Study Completion: 2020-11-07
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PoCUS Guided Resuscitation of Shock	PoCUS Guided Resuscitation of Shock	Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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Revoked deferred consent rate	28 days	Proportion of participants whose consent was revoked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

Trial Locations

Locations (1)

London Health Science Center - Critical Care Trauma Center; 🇨🇦 London, Ontario, Canada