Guidance of Ultrasound in Intensive Care to Direct Euvolemia

NCT03938038 | Completed Results FDA Device

• 1 other identifier: HSC-MS-19-0425
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness of routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation in reducing acute kidney injury (AKI) incidence and duration in trauma patients in a teaching institution.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Number of Acute Kidney Injury (AKI)-Free Days

  AKI will be defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria, and all stages will be considered AKI: Stage 1 - Serum Creatinine 1.5-1.9 times baseline or ≥0.3 mg/dL increase Stage 2 - Serum Creatinine 2-2.9 times baseline Stage 3 - Serum Creatinine 3 times baseline or Increase in serum creatinine to ≥4 mg/dL or Initiation of renal replacement therapy

  within 7 days of injury

• Number of Participants Who Receive 3 or More Ultrasound Volume Assessments

  within 24 hours of ICU admission

Secondary Outcomes (14)

• Number of Participants With Acute Kidney Injury (AKI)

  within the first 7 days of ICU admission

• Stage of Acute Kidney Injury (AKI)

  within the first 7 days of ICU admission

• Number of Participants With Need for Renal Replacement Therapy

  within the first 30 days of ICU admission

• Quantity of Fluids Administered

  24 hours

• Quantity of Fluids Administered

  48 hours

Study Arms (2)

Serial ultrasound assessments for GDT, then Usual Care

ACTIVE COMPARATOR

Diagnostic Test: Serial ultrasound assessments for GDT; Diagnostic Test: Usual care

Usual care, then Serial ultrasound assessments for GDT

ACTIVE COMPARATOR

Diagnostic Test: Serial ultrasound assessments for GDT; Diagnostic Test: Usual care

Interventions

Serial ultrasound assessments for GDT DIAGNOSTIC_TEST

routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation

Serial ultrasound assessments for GDT, then Usual Care; Usual care, then Serial ultrasound assessments for GDT

Usual care DIAGNOSTIC_TEST

Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback

Serial ultrasound assessments for GDT, then Usual Care; Usual care, then Serial ultrasound assessments for GDT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Injured patients that are admitted to the trauma ICU

You may not qualify if:

• Incarceration
• Pregnancy

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Gabrielle Hatton, MD
• Organization: The University of Texas Health Science Center at Houston

gabrielle.e.hatton@uth.tmc.edu

713-500-7211

Study Officials

• Gabrielle Hatton, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: Randomization will not occur at the individual patient level. Instead, assessment techniques (US-guided versus usual care) will be randomly assigned to care team clusters. Because teams change each month, the assignment will be to US-guided care during the first half or the second half of the month.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: September 6, 2019
• Primary Completion: June 27, 2020
• Study Completion: July 20, 2020
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)