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出境医 / 临床实验 / Guidance of Ultrasound in Intensive Care to Direct Euvolemia (GUIDE)

Guidance of Ultrasound in Intensive Care to Direct Euvolemia (GUIDE)

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Diagnostic Test: Serial ultrasound assessments for GDT Diagnostic Test: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Serial ultrasound assessments for GDT Diagnostic Test: Serial ultrasound assessments for GDT
routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation
Active Comparator: Usual care Diagnostic Test: Usual care
Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Outcome Measures
Primary Outcome Measures :
  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. Proportion of patients who receive 3 or more Ultrasound Volume Assessments [ Time Frame: within 24 hours of ICU admission ]

Secondary Outcome Measures :
  1. Number of participants with 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 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. Time to lactate normalization [ Time Frame: within the first 7 days of ICU admission ]
  9. Time to creatinine concentration <1.5 mg/dL or to prehospital baseline [ Time Frame: within the first 7 days of ICU admission ]
  10. Time to base excess normalization [ Time Frame: within the first 7 days of ICU admission ]
  11. Number of ventilator-free days [ Time Frame: within first 30 days after injury ]
  12. Number of ICU-free days [ Time Frame: within first 30 days after injury ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Injured patients that are admitted to the trauma ICU

Exclusion Criteria:

  • Incarceration
  • Pregnancy
Contacts and Locations

Contacts
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Contact: Gabrielle E Hatton, MD 713-500-7211 gabrielle.e.hatton@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Gabrielle E Hatton, MD    713-500-7211    gabrielle.e.hatton@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Gabrielle Hatton, MD The University of Texas Health Science Center, Houston
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE September 6, 2019
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • 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
  • Proportion of patients who receive 3 or more Ultrasound Volume Assessments [ Time Frame: within 24 hours of ICU admission ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Number of participants with 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
  • Stage of 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
  • Number of participants with need for renal replacement therapy [ Time Frame: within the first 30 days of ICU admission ]
  • Quantity of fluids administered [ Time Frame: 24 hours ]
  • Quantity of fluids administered [ Time Frame: 48 hours ]
  • Type of fluids administered [ Time Frame: 24 hours ]
  • Type of fluids administered [ Time Frame: 48 hours ]
  • Time to lactate normalization [ Time Frame: within the first 7 days of ICU admission ]
  • Time to creatinine concentration <1.5 mg/dL or to prehospital baseline [ Time Frame: within the first 7 days of ICU admission ]
  • Time to base excess normalization [ Time Frame: within the first 7 days of ICU admission ]
  • Number of ventilator-free days [ Time Frame: within first 30 days after injury ]
  • Number of ICU-free days [ Time Frame: within first 30 days after injury ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Guidance of Ultrasound in Intensive Care to Direct Euvolemia
Official Title  ICMJE Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • Diagnostic Test: Serial ultrasound assessments for GDT
    routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation
  • Diagnostic Test: Usual care
    Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Study Arms  ICMJE
  • Active Comparator: Serial ultrasound assessments for GDT
    Intervention: Diagnostic Test: Serial ultrasound assessments for GDT
  • Active Comparator: Usual care
    Intervention: Diagnostic Test: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Injured patients that are admitted to the trauma ICU

Exclusion Criteria:

  • Incarceration
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gabrielle E Hatton, MD 713-500-7211 gabrielle.e.hatton@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938038
Other Study ID Numbers  ICMJE 2019-330
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gabrielle Hatton, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabrielle Hatton, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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