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

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ClinicalTrials.gov Identifier: NCT03938038
Recruitment Status : Not yet recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Gabrielle Hatton, 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.

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

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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)
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938038


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 Not yet 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

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Responsible Party: Gabrielle Hatton, Research Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03938038     History of Changes
Other Study ID Numbers: 2019-330
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases