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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serial ultrasound assessments for GDT
Usual care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Kidney Injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Injured patients that are admitted to the trauma ICU

Exclusion Criteria:

  • Incarceration
  • Pregnancy

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Serial ultrasound assessments for GDT

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Number of acute kidney injury (AKI)-free days
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

Secondary Outcome Measures

Number of participants with AKI
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
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
Quantity of fluids administered
Quantity of fluids administered
Type of fluids administered
Type of fluids administered
Time to lactate normalization
Time to creatinine concentration <1.5 mg/dL or to prehospital baseline
Time to base excess normalization
Number of ventilator-free days
Number of ICU-free days

Full Information

First Posted
May 2, 2019
Last Updated
June 3, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03938038
Brief Title
Guidance of Ultrasound in Intensive Care to Direct Euvolemia
Acronym
GUIDE
Official Title
Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
June 27, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Serial ultrasound assessments for GDT
Arm Type
Active Comparator
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Serial ultrasound assessments for GDT
Intervention Description
routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation
Intervention Type
Diagnostic Test
Intervention Name(s)
Usual care
Intervention Description
Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Primary Outcome Measure Information:
Title
Number of acute kidney injury (AKI)-free days
Description
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
Time Frame
within 7 days of injury
Title
Proportion of patients who receive 3 or more Ultrasound Volume Assessments
Time Frame
within 24 hours of ICU admission
Secondary Outcome Measure Information:
Title
Number of participants with AKI
Description
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
Time Frame
within the first 7 days of ICU admission
Title
Stage of AKI
Description
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
Time Frame
within the first 7 days of ICU admission
Title
Number of participants with need for renal replacement therapy
Time Frame
within the first 30 days of ICU admission
Title
Quantity of fluids administered
Time Frame
24 hours
Title
Quantity of fluids administered
Time Frame
48 hours
Title
Type of fluids administered
Time Frame
24 hours
Title
Type of fluids administered
Time Frame
48 hours
Title
Time to lactate normalization
Time Frame
within the first 7 days of ICU admission
Title
Time to creatinine concentration <1.5 mg/dL or to prehospital baseline
Time Frame
within the first 7 days of ICU admission
Title
Time to base excess normalization
Time Frame
within the first 7 days of ICU admission
Title
Number of ventilator-free days
Time Frame
within first 30 days after injury
Title
Number of ICU-free days
Time Frame
within first 30 days after injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Injured patients that are admitted to the trauma ICU Exclusion Criteria: Incarceration Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabrielle Hatton, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Guidance of Ultrasound in Intensive Care to Direct Euvolemia

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