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NCT Number: NCT03938038

Guidance of Ultrasound in Intensive Care to Direct Euvolemia

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Injured patients that are admitted to the trauma ICU

Exclusion criteria

  • Incarceration
  • Pregnancy

Treatment and study plan

Serial ultrasound assessments for GDT

Diagnostic Test

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

Usual Care

Diagnostic Test

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

Primary outcomes

  1. 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

  2. Number of Participants Who Receive 3 or More Ultrasound Volume Assessments

    Time frame: within 24 hours of ICU admission

Secondary outcomes

  1. Number of Participants With Acute Kidney Injury (AKI)

    Time frame: 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

  2. Stage of Acute Kidney Injury (AKI)

    Time frame: 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

  3. Number of Participants With Need for Renal Replacement Therapy

    Time frame: within the first 30 days of ICU admission

  4. Quantity of Fluids Administered

    Time frame: 24 hours

  5. Quantity of Fluids Administered

    Time frame: 48 hours

  6. Type of Fluids Administered

    Time frame: 24 hours

  7. Type of Fluids Administered

    Time frame: 48 hours

  8. Quantity of Diuretics Administered

    Time frame: 24 hours

  9. Quantity of Diuretics Administered

    Time frame: 48 hours

  10. Time to Lactate Normalization

    Time frame: within the first 7 days of ICU admission

  11. Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline

    Time frame: within the first 7 days of ICU admission

  12. Time to Base Excess Normalization

    Time frame: within the first 7 days of ICU admission

  13. Number of Ventilator-free Days

    Time frame: within first 30 days after injury

  14. Number of ICU-free Days

    Time frame: within first 30 days after injury

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: GUIDE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 6, 2019
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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