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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296891
• Other study ID #: 109038
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: November 7, 2020

Study information

• Verified date: September 2017
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 7, 2020
• Est. primary completion date: November 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Shock

Intervention

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).

Locations

Country	Name	City	State
Canada	London Health Science Center - Critical Care Trauma Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

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Secondary	Revoked deferred consent rate	Proportion of participants whose consent was revoked	28 days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