Ultrasound-Guided Resuscitation in Open Aortic Surgery

NCT04180553 | Unknown DMC

• 1 other identifier: 113875
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ultrasound; Goal-directed resuscitation

Outcome Measures

Primary Outcomes (6)

• Feasibility - Recruitment

  Recruitment - Overall proportion of eligible patients successfully entered into the study divided by the total number of eligible patients consented and retained to full data completion - ≥80% recruitment rate

  30 days

• Feasibility - Successful Randomization

  Overall proportion of consented patients successfully receiving randomization at the completion of operation divided by the total number of consented patients - ≥80% randomized

  30 days

• Feasibility - POCUS Study completion

  Overall proportion of completed studies divided by expected studies - ≥80% completion

  30 days

• Feasibility - Protocol Adherence

  Overall proportion of patients adequately receiving treatment as defined by the trial protocol divided by the total number of patients enrolled - ≥80% Adherence

  30 days

• Feasibility - Successful Data Collection

  Overall proportion of patients with no absent data points in the database divided by the total number of patients enrolled - ≥80% complete data sets

  30 days

• Feasibility - Contamination rate

  The number of patients crossed over into the opposite arm of the study based on patient or physician motivators divided by the total number of patients enrolled - ≤20% contamination

  30 days

Secondary Outcomes (1)

• Feasibility - POCUS image quality

  30 days

Study Arms (2)

Point-Of-Care Ultrasound Guided Resuscitation

EXPERIMENTAL

Intervention in this trial is randomization to POCUS management for goal-directed post-operative resuscitation for the first 48 hours of admission.Patients randomized to the use of POCUS will have a focused cardiac, thoracic, and IVC study performed post-operatively in PACU, as well as regular (BID) assessments on the inpatient ward for post-operative day one and two. Based on ultrasound findings, their fluid resuscitation will be guided to a fluid liberal or fluid restrictive strategy at the time of each assessment.

Diagnostic Test: Point of Care Ultrasound (POCUS)

Usual Care

ACTIVE COMPARATOR

The comparator arm in this trial is randomization to usual care. Participants randomized to 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

Other: Usual Care

Interventions

Point of Care Ultrasound (POCUS) DIAGNOSTIC_TEST

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.

Point-Of-Care Ultrasound Guided Resuscitation

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

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

You may qualify if:

• Patients must be 18 years of age or older.
• o There is no upper age limit for eligibility in this study.
• Elective surgical procedures
• Patients who are enrolled must be receiving open abdominal surgery for either occlusive disease (aortobifemoral bypass, transaortic endarterectomy) or aneurysmal disease (infrarenal, juxtarenal abdominal aortic aneurysms).
• Patients must be deemed suitable operative candidates for open abdominal aortic surgery as decided upon by the surgical and perioperative medicine assessments.

You may not qualify if:

• Thoracoabdominal aneurysms (Type IV or larger extent)
• Hybrid procedures (Requiring both endovascular and open surgical reconstruction)
• Pediatric vascular cases (Patients less than 18 years of age)
• Emergency cases
• American Society of Anesthesia (ASA) class 5 identified
• Chronic renal failure requiring dialysis
• Inability of patient to consent to study

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Health Sciences Center - Victoria Hospital

London, Ontario, N6A5W9, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luc Dubois, MD

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John H Landau, MD

CONTACT

519.685.8500; john.landau@londonhospitals.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial - 20 patients per arm. A permuted block randomization plan will be used with block sizes of 2 and 4

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 27, 2019
• Study Start: January 15, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)