Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Study Overview
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Brief Summary
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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.

Official Title
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Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Diagnostic Test: Serial ultrasound assessments for GDT
* Diagnostic Test: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Injured patients that are admitted to the trauma ICU Exclusion Criteria: Incarceration Pregnancy

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Serial ultrasound assessments for GDT<br> | Diagnostic Test: Serial ultrasound assessments for GDT<br>* routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation<br>|
| Active Comparator: Usual care<br> | Diagnostic Test: Usual care<br>* Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 7 days of injury | 
| Proportion of patients who receive 3 or more Ultrasound Volume Assessments |  | within 24 hours of ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within the first 7 days of ICU admission | 
| 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 | within the first 7 days of ICU admission | 
| Number of participants with need for renal replacement therapy |  | within the first 30 days of ICU admission | 
| Quantity of fluids administered |  | 24 hours | 
| Quantity of fluids administered |  | 48 hours | 
| Type of fluids administered |  | 24 hours | 
| Type of fluids administered |  | 48 hours | 
| Time to lactate normalization |  | within the first 7 days of ICU admission | 
| Time to creatinine concentration <1.5 mg/dL or to prehospital baseline |  | within the first 7 days of ICU admission | 
| Time to base excess normalization |  | within the first 7 days of ICU admission | 
| Number of ventilator-free days |  | within first 30 days after injury | 
| Number of ICU-free days |  | within first 30 days after injury |