Acute Kidney Injury
Conditions
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.
Interventions
DIAGNOSTIC_TESTSerial ultrasound assessments for GDT
routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation
DIAGNOSTIC_TESTUsual care
Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Injured patients that are admitted to the trauma ICU
Exclusion criteria
* Incarceration * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of Participants Who Receive 3 or More Ultrasound Volume Assessments | within 24 hours of ICU admission | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Need for Renal Replacement Therapy | within the first 30 days of ICU admission | — |
| Quantity of Fluids Administered | 24 hours | — |
| Type of Fluids Administered | 24 hours | — |
| Quantity of Diuretics Administered | 24 hours | — |
| Number of Participants With Acute Kidney Injury (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 |
| 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 | — |
| Time to Lactate Normalization | within the first 7 days of ICU admission | — |
| Stage of Acute Kidney Injury (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 |
Countries
United States
Participant flow
Pre-assignment details
Eight different care team clusters will be randomly assigned to either US-guided care or usual care during the 1st half the month and the other technique in the 2nd half. Patient participants will receive either US-guided care or usual care, but not both, and the technique a patient participant receives depends on whether they receive treatment in the 1st or 2nd half of the month. 4 of the 415 enrolled were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Serial Ultrasound Assessments for GDT Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation | 222 |
| Usual Care Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback | 189 |
| Total | 411 |
Baseline characteristics
| Characteristic | Serial Ultrasound Assessments for GDT | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 37 years | 39.5 years | 38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 36 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants | 134 Participants | 285 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 27 Participants | 19 Participants | 46 Participants |
| Region of Enrollment United States | 222 participants | 189 participants | 411 participants |
| Sex: Female, Male Female | 76 Participants | 54 Participants | 130 Participants |
| Sex: Female, Male Male | 146 Participants | 135 Participants | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 222 | 15 / 189 |
| other Total, other adverse events | 115 / 222 | 119 / 189 |
| serious Total, serious adverse events | 23 / 222 | 15 / 189 |
Outcome results
Primary
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
Time frame: within 7 days of injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Number of Acute Kidney Injury (AKI)-Free Days | 1 Days |
| Usual Care | Number of Acute Kidney Injury (AKI)-Free Days | 1 Days |
Primary
Number of Participants Who Receive 3 or More Ultrasound Volume Assessments
Time frame: within 24 hours of ICU admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Number of Participants Who Receive 3 or More Ultrasound Volume Assessments | 7 Participants |
| Usual Care | Number of Participants Who Receive 3 or More Ultrasound Volume Assessments | 0 Participants |
Secondary
Number of ICU-free Days
Time frame: within first 30 days after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Number of ICU-free Days | 26 days |
| Usual Care | Number of ICU-free Days | 26 days |
Secondary
Number of Participants With Acute Kidney Injury (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
Time frame: within the first 7 days of ICU admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Number of Participants With Acute Kidney Injury (AKI) | 115 Participants |
| Usual Care | Number of Participants With Acute Kidney Injury (AKI) | 119 Participants |
Secondary
Number of Participants With Need for Renal Replacement Therapy
Time frame: within the first 30 days of ICU admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Number of Participants With Need for Renal Replacement Therapy | 16 Participants |
| Usual Care | Number of Participants With Need for Renal Replacement Therapy | 18 Participants |
Secondary
Number of Ventilator-free Days
Time frame: within first 30 days after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Number of Ventilator-free Days | 29 days |
| Usual Care | Number of Ventilator-free Days | 29 days |
Secondary
Quantity of Diuretics Administered
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serial Ultrasound Assessments for GDT | Quantity of Diuretics Administered | 0 milliliter (mL) | Standard Deviation 0 |
| Usual Care | Quantity of Diuretics Administered | 0 milliliter (mL) | Standard Deviation 0 |
Secondary
Quantity of Diuretics Administered
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Serial Ultrasound Assessments for GDT | Quantity of Diuretics Administered | 0 milliliter (mL) | Standard Deviation 0 |
| Usual Care | Quantity of Diuretics Administered | 0 milliliter (mL) | Standard Deviation 0 |
Secondary
Quantity of Fluids Administered
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Quantity of Fluids Administered | 1562 milliliter (mL) |
| Usual Care | Quantity of Fluids Administered | 1471 milliliter (mL) |
Secondary
Quantity of Fluids Administered
Time frame: 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Serial Ultrasound Assessments for GDT | Quantity of Fluids Administered | 1215 milliliter (mL) |
| Usual Care | Quantity of Fluids Administered | 572 milliliter (mL) |
Secondary
Stage of Acute Kidney Injury (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
Time frame: within the first 7 days of ICU admission
Population: Data were not collected for 107 participants in the Serial Ultrasound Assessments for GDT arm because they did not have AKI. Data were not collected for 70 participants in the usual care arm because they did not have AKI.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Serial Ultrasound Assessments for GDT | Stage of Acute Kidney Injury (AKI) | Stage 1 | 67 Participants |
| Serial Ultrasound Assessments for GDT | Stage of Acute Kidney Injury (AKI) | Stage 2 | 32 Participants |
| Serial Ultrasound Assessments for GDT | Stage of Acute Kidney Injury (AKI) | Stage 3 | 16 Participants |
| Usual Care | Stage of Acute Kidney Injury (AKI) | Stage 1 | 64 Participants |
| Usual Care | Stage of Acute Kidney Injury (AKI) | Stage 2 | 37 Participants |
| Usual Care | Stage of Acute Kidney Injury (AKI) | Stage 3 | 18 Participants |
Secondary
Time to Base Excess Normalization
Time frame: within the first 7 days of ICU admission
Population: Data were not collected for this outcome measure.
Secondary
Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline
Time frame: within the first 7 days of ICU admission
Population: Data were not collected for this outcome measure.
Secondary
Time to Lactate Normalization
Time frame: within the first 7 days of ICU admission
Population: Data were not collected for this outcome measure.
Secondary
Type of Fluids Administered
Time frame: 24 hours
Population: Data were not collected for this outcome measure.
Secondary
Type of Fluids Administered
Time frame: 48 hours
Population: Data were not collected for this outcome measure.