Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serial ultrasound assessments for GDT, then Usual Care | Active Comparator |
| |
| Usual care, then Serial ultrasound assessments for GDT | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serial ultrasound assessments for GDT | Diagnostic Test | routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation |
| 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 |
| Number of Participants Who Receive 3 or More Ultrasound Volume Assessments | within 24 hours of ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gabrielle Hatton, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Serial Ultrasound Assessments for GDT, Then Usual Care | Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback |
| FG001 | Usual Care, Then Serial Ultrasound Assessments for GDT | Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Half of the Month (15 Days) |
| |||||||||||||
| Second Half of the Month (15 Days) |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | Days | within 7 days of injury |
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | TQIP | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | TQIP | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabrielle Hatton, MD | The University of Texas Health Science Center at Houston | 713-500-7211 | gabrielle.e.hatton@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 3, 2019 | Jun 29, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Usual care | Diagnostic Test | Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback |
|
| within the first 7 days of ICU admission |
| 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 | 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 |
| Quantity of Diuretics Administered | 24 hours |
| Quantity of Diuretics 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 |
| NOT COMPLETED |
|
Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
|
|
| Primary | Number of Participants Who Receive 3 or More Ultrasound Volume Assessments | Posted | Count of Participants | Participants | within 24 hours of ICU admission |
|
|
|
| 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 | Posted | Count of Participants | Participants | within the first 7 days of ICU admission |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | within the first 7 days of ICU admission |
|
|
|
| Secondary | Number of Participants With Need for Renal Replacement Therapy | Posted | Count of Participants | Participants | within the first 30 days of ICU admission |
|
|
|
| Secondary | Quantity of Fluids Administered | Posted | Median | Inter-Quartile Range | milliliter (mL) | 24 hours |
|
|
|
| Secondary | Quantity of Fluids Administered | Posted | Median | Inter-Quartile Range | milliliter (mL) | 48 hours |
|
|
|
| Secondary | Type of Fluids Administered | Data were not collected for this outcome measure. | Posted | 24 hours |
|
|
| Secondary | Type of Fluids Administered | Data were not collected for this outcome measure. | Posted | 48 hours |
|
|
| Secondary | Quantity of Diuretics Administered | Posted | Mean | Standard Deviation | milliliter (mL) | 24 hours |
|
|
|
| Secondary | Quantity of Diuretics Administered | Posted | Mean | Standard Deviation | milliliter (mL) | 48 hours |
|
|
|
| Secondary | Time to Lactate Normalization | Data were not collected for this outcome measure. | Posted | within the first 7 days of ICU admission |
|
|
| Secondary | Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline | Data were not collected for this outcome measure. | Posted | within the first 7 days of ICU admission |
|
|
| Secondary | Time to Base Excess Normalization | Data were not collected for this outcome measure. | Posted | within the first 7 days of ICU admission |
|
|
| Secondary | Number of Ventilator-free Days | Posted | Median | Inter-Quartile Range | days | within first 30 days after injury |
|
|
|
| Secondary | Number of ICU-free Days | Posted | Median | Inter-Quartile Range | days | within first 30 days after injury |
|
|
|
| 21 |
| 222 |
| 23 |
| 222 |
| 115 |
| 222 |
| EG001 | Usual Care | Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback | 15 | 189 | 15 | 189 | 119 | 189 |
| New Onset Congestive Heart Failure | Cardiac disorders | TQIP | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Stage 3 |
|