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Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Not Applicable
Completed
Conditions
Acute Kidney Injury
Interventions
Diagnostic Test: Serial ultrasound assessments for GDT
Diagnostic Test: Usual care
Registration Number
NCT03938038
Lead Sponsor
The University of Texas Health Science Center, Houston
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
415
Inclusion Criteria
  • Injured patients that are admitted to the trauma ICU
Exclusion Criteria
  • Incarceration
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Serial ultrasound assessments for GDT, then Usual CareSerial ultrasound assessments for GDT-
Serial ultrasound assessments for GDT, then Usual CareUsual care-
Usual care, then Serial ultrasound assessments for GDTUsual care-
Usual care, then Serial ultrasound assessments for GDTSerial ultrasound assessments for GDT-
Primary Outcome Measures
NameTimeMethod
Number of Participants Who Receive 3 or More Ultrasound Volume Assessmentswithin 24 hours of ICU admission
Number of Acute Kidney Injury (AKI)-Free Dayswithin 7 days of injury

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

Secondary Outcome Measures
NameTimeMethod
Type of Fluids Administered48 hours
Number of Participants With Acute Kidney Injury (AKI)within the first 7 days of ICU admission

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

Quantity of Fluids Administered48 hours
Quantity of Diuretics Administered48 hours
Time to Lactate Normalizationwithin the first 7 days of ICU admission
Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baselinewithin the first 7 days of ICU admission
Number of Participants With Need for Renal Replacement Therapywithin the first 30 days of ICU admission
Number of ICU-free Dayswithin first 30 days after injury
Stage of Acute Kidney Injury (AKI)within the first 7 days of ICU admission

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

Number of Ventilator-free Dayswithin first 30 days after injury
Time to Base Excess Normalizationwithin the first 7 days of ICU admission

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

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