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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Clinicaltrials.gov identifier NCT03938038

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted November 14, 2019

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:Acute Kidney Injury
  • Intervention/Treatment: Diagnostic Test: Serial ultrasound assessments for GDT
    Diagnostic Test: Usual care
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: October 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. Quantity of fluids administered [ Time Frame: 24 hours ]
  • 2. Quantity of fluids administered [ Time Frame: 48 hours ]
  • 3. Type of fluids administered [ Time Frame: 24 hours ]
  • 4. Type of fluids administered [ Time Frame: 48 hours ]
  • 5. Time to lactate normalization [ Time Frame: within the first 7 days of ICU admission ]
  • 6. Number of participants with need for renal replacement therapy [ Time Frame: within the first 30 days of ICU admission ]
  • 7. 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
  • 8. 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
  • 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
  • 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

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

Locations

United States, Texas
The University of Texas Health Science Center at Houston
Houston

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator: Gabrielle Hatton, MD The University of Texas Health Science Center, Houston

More Information
  • Responsible Party: 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: November 14, 2019
  • Last Verified: November 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes
  • Additional relevant MeSH terms: Acute Kidney Injury