Guidance of Ultrasound in Intensive Care to Direct Euvolemia

NCT ID: NCT03938038

Last Updated: 2024-04-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2020-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Serial ultrasound assessments for GDT, then Usual Care

Group Type ACTIVE_COMPARATOR

Serial ultrasound assessments for GDT

Intervention Type DIAGNOSTIC_TEST

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

Usual care

Intervention Type DIAGNOSTIC_TEST

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

Usual care, then Serial ultrasound assessments for GDT

Group Type ACTIVE_COMPARATOR

Serial ultrasound assessments for GDT

Intervention Type DIAGNOSTIC_TEST

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

Usual care

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Serial ultrasound assessments for GDT

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

Intervention Type DIAGNOSTIC_TEST

Usual care

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Injured patients that are admitted to the trauma ICU

Exclusion Criteria

* Incarceration
* Pregnancy
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Gabrielle Hatton

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabrielle Hatton, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MS-19-0425

Identifier Type: -

Identifier Source: org_study_id

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