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Clinical Trials/NCT03938038
NCT03938038
Completed
Not Applicable

Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)

The University of Texas Health Science Center, Houston1 site in 1 country415 target enrollmentSeptember 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
415
Locations
1
Primary Endpoint
Number of Participants Who Receive 3 or More Ultrasound Volume Assessments
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2019
End Date
July 20, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gabrielle Hatton

Research Fellow

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Injured patients that are admitted to the trauma ICU

Exclusion Criteria

  • Incarceration
  • Pregnancy

Outcomes

Primary Outcomes

Number of Participants Who Receive 3 or More Ultrasound Volume Assessments

Time Frame: within 24 hours of ICU admission

Number of Acute Kidney Injury (AKI)-Free Days

Time Frame: within 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 Outcomes

  • Number of Participants With Acute Kidney Injury (AKI)(within the first 7 days of ICU admission)
  • Quantity of Fluids Administered(48 hours)
  • Quantity of Diuretics Administered(48 hours)
  • Time to Lactate Normalization(within the first 7 days of ICU admission)
  • Type of Fluids Administered(48 hours)
  • Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline(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)
  • Number of ICU-free Days(within first 30 days after injury)
  • Stage of Acute Kidney Injury (AKI)(within the first 7 days of ICU admission)
  • Number of Ventilator-free Days(within first 30 days after injury)
  • Time to Base Excess Normalization(within the first 7 days of ICU admission)

Study Sites (1)

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