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

NCT03296891 | Completed

• 1 other identifier: 109038
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Shock; Hypotension

Keywords

Ultrasonography; Point-of-care ultrasound; Resuscitation; Critical Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Mortality

  28 days

• Successful randomization rate

  28 days

• Protocol adherence rate

  28 days

• Contamination rate

  28 days

• Revoked deferred consent rate

  28 days

Study Arms (2)

PoCUS Guided Resuscitation of Shock

ACTIVE COMPARATOR

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

Other: PoCUS Guided Resuscitation of Shock

Usual Care

NO INTERVENTION

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

Interventions

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).

PoCUS Guided Resuscitation of Shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Science Center - Critical Care Trauma Center

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Conditions

Shock; Hypotension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: September 10, 2017
• Primary Completion: November 7, 2020
• Study Completion: November 7, 2020
• Last Updated: December 19, 2020

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)