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GUIDE: Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03938038
Collaborator
(none)
415
Enrollment
1
Location
2
Arms
10.4
Actual Duration (Months)
39.7
Patients Per Site Per Month

Study Details

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
  • Diagnostic Test: Serial ultrasound assessments for GDT
  • Diagnostic Test: Usual care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
415 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.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 :
Sep 6, 2019
Actual Primary Completion Date :
Jun 27, 2020
Actual Study Completion Date :
Jul 20, 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 [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 [within 24 hours of ICU admission]

Secondary Outcome Measures

  1. Number of participants with AKI [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 [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 [within the first 30 days of ICU admission]

  4. Quantity of fluids administered [24 hours]

  5. Quantity of fluids administered [48 hours]

  6. Type of fluids administered [24 hours]

  7. Type of fluids administered [48 hours]

  8. Time to lactate normalization [within the first 7 days of ICU admission]

  9. Time to creatinine concentration <1.5 mg/dL or to prehospital baseline [within the first 7 days of ICU admission]

  10. Time to base excess normalization [within the first 7 days of ICU admission]

  11. Number of ventilator-free days [within first 30 days after injury]

  12. Number of ICU-free days [within first 30 days after injury]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Injured patients that are admitted to the trauma ICU
Exclusion Criteria:

  • Incarceration

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gabrielle Hatton, Research Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03938038
Other Study ID Numbers:
  • HSC-MS-19-0425
First Posted:
May 6, 2019
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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.:
No
Additional relevant MeSH terms:
Acute Kidney Injury

Study Results

No Results Posted as of Jun 11, 2021