NCT03938038 - Guidance of Ultrasound in Intensive Care to Direct Euvolemia | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

415

Conditions

Acute Kidney Injury

Interventions

Serial ultrasound assessments for GDTDIAGNOSTIC_TEST

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

Usual careDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Injured patients that are admitted to the trauma ICU Exclusion Criteria: * Incarceration * Pregnancy

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: within 7 days of injury

Number of Participants Who Receive 3 or More Ultrasound Volume Assessments

Time frame: within 24 hours of ICU admission

Secondary Outcomes

Number of Participants With Acute Kidney Injury (AKI)

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

Time frame: within the first 7 days of ICU admission

Stage of Acute Kidney Injury (AKI)

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

Time frame: within the first 7 days of ICU admission

Number of Participants With Need for Renal Replacement Therapy

Time frame: within the first 30 days of ICU admission

Quantity of Fluids Administered