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Ultrasound-Guided Resuscitation in Open Aortic Surgery

NCT04180553 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-24

No results posted yet for this study

Summary

This study will aim to determine whether routine Point of Care Ultrasound (POCUS) assessment of volume status, cardiac function, and pulmonary function after major abdominal aortic surgery is an accurate and feasible form of monitoring for individualized, goal-directed resuscitation. Half of the patients will receive POCUS-guided fluid resuscitation, and the other half will be resuscitated using usual post-operative care.

Conditions

  • Aortic Diseases

Interventions

DIAGNOSTIC_TEST

Point of Care Ultrasound (POCUS)

The intervention group will receive a 4-view transthoracic echocardiogram including Parasternal long axis, parasternal short axis, apical 4-chamber, and supplemental subcostal short-axis/4-chamber views as needed. A standard 4-view thoracic lung ultrasound study will assess the left and right anterior chest wall, anterior axillary regions, as well as the costophrenic angle and posterolateral regions. At 5 discrete time intervals post-operatively, POCUS assessments will be used to adjust fluid resuscitation to fluid liberal (2cc/kg/hr) or fluid restrictive (0.8cc/kg/hr). Routine vital signs, biochemistry, and urine output as well as bedside physical exam will be assessed as usual. IV boluses of crystalloid will be permitted to treat hypotension with SBP \<90mmHg with clinical signs of hypovolemia, but oliguria will not be used as a marker to titrate fluid infusion rates. Blood transfusion may be used for post-operative bleeding or anemia as clinically indicated.

OTHER

Usual Care

The control group for "usual care" will undergo resuscitation guided by modalities used currently, which can include both static and dynamic measures. These will include review of vital signs, biochemistry, and urine output as well as bedside physical exam. In this arm, patients will not undergo POCUS during their admission. IV fluid infusion rates as well as targets for IV boluses will be left to the discretion of the attending physician and can include hypotension, hypovolemia, as well as oliguria. Blood transfusion may be used for post-operative bleeding or anemia as clinically indicated.

Sponsors & Collaborators

  • London Health Sciences Centre

    lead OTHER

Principal Investigators

  • Luc Dubois, MD · London Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-10-30
Completion
2021-12-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04180553 on ClinicalTrials.gov