Acute Kidney InjuryGUIDENCT03938038
Guidance of Ultrasound in Intensive Care to Direct Euvolemia
A study testing Serial ultrasound assessments for GDT in people with Acute Kidney Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Serial ultrasound assessments for GDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 20 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Injured patients that are admitted to the trauma ICU
Who cannot join
- Incarceration
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Serial ultrasound assessments for GDT, Usual care
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial ultrasound assessments for GDTDiagnostic test
routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation
Usual careDiagnostic test
Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
| Study group | Role | What they receive |
|---|---|---|
| Serial ultrasound assessments for GDT, then Usual Care | Active comparator | Not described Receives: Diagnostic Test: Serial ultrasound assessments for GDT; Diagnostic Test: Usual care |
| Usual care, then Serial ultrasound assessments for GDT | Active comparator | Not described Receives: Diagnostic Test: Serial ultrasound assessments for GDT; Diagnostic Test: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7 days of injury
Number of Participants Who Receive 3 or More Ultrasound Volume Assessments
Measured: within 24 hours of ICU admission
Secondary outcomes (14)
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
Measured: 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
Measured: within the first 7 days of ICU admission
Number of Participants With Need for Renal Replacement Therapy
Measured: within the first 30 days of ICU admission
Quantity of Fluids Administered
Measured: 24 hours
Quantity of Fluids Administered
Measured: 48 hours
Type of Fluids Administered
Measured: 24 hours
Type of Fluids Administered
Measured: 48 hours
Quantity of Diuretics Administered
Measured: 24 hours
Quantity of Diuretics Administered
Measured: 48 hours
Time to Lactate Normalization
Measured: within the first 7 days of ICU admission
Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline
Measured: within the first 7 days of ICU admission
Time to Base Excess Normalization
Measured: within the first 7 days of ICU admission
Number of Ventilator-free Days
Measured: within first 30 days after injury
Number of ICU-free Days
Measured: within first 30 days after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start6 Sep 2019
- Primary completion27 Jun 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabrielle Hatton, The University of Texas Health Science Center, Houston
- Investigators
- Gabrielle Hatton, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938038
- Sponsor's protocol ID
- HSC-MS-19-0425
- Acronym
- GUIDE
- Status last verified
- Mar 2024
- First submitted
- 2 May 2019
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guidance of Ultrasound in Intensive Care to Direct Euvolemia: A Cluster Randomized Crossover Comparative Effectiveness Trial (GUIDE Trial)
- ClinicalTrials.gov ID
- NCT03938038
- Acronym / sponsor ID
- GUIDE / HSC-MS-19-0425
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 27 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Serial ultrasound assessments for GDT, then Usual Care | Active comparator | Diagnostic Test: Serial ultrasound assessments for GDT, Diagnostic Test: Usual care |
| Usual care, then Serial ultrasound assessments for GDT | Active comparator | Diagnostic Test: Serial ultrasound assessments for GDT, Diagnostic Test: Usual care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Injured patients that are admitted to the trauma ICU
Key exclusion criteria (2 listed)
- Incarceration
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial ultrasound assessments for GDTroutine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation | Diagnostic test | Serial ultrasound assessments for GDT, then Usual Care, Usual care, then Serial ultrasound assessments for GDT |
| Usual careClose hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback | Diagnostic test | Serial ultrasound assessments for GDT, then Usual Care, Usual care, then Serial ultrasound assessments for GDT |
Primary outcome
Number of Acute Kidney Injury (AKI)-Free Days
Time frame: 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
Time frame: within 24 hours of ICU admission
14 secondary outcomes
Number of Participants With Acute Kidney Injury (AKI)
Time frame: within the first 7 days of ICU admission
Stage of Acute Kidney Injury (AKI)
Time frame: within the first 7 days of ICU admission
Number of Participants With Need for Renal Replacement Therapy
Time frame: within the first 30 days of ICU admission
Quantity of Fluids Administered
Time frame: 24 hours
Quantity of Fluids Administered
Time frame: 48 hours
Type of Fluids Administered
Time frame: 24 hours
Type of Fluids Administered
Time frame: 48 hours
Quantity of Diuretics Administered
Time frame: 24 hours
Quantity of Diuretics Administered
Time frame: 48 hours
Time to Lactate Normalization
Time frame: within the first 7 days of ICU admission
Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline
Time frame: within the first 7 days of ICU admission
Time to Base Excess Normalization
Time frame: within the first 7 days of ICU admission
Number of Ventilator-free Days
Time frame: within first 30 days after injury
Number of ICU-free Days
Time frame: within first 30 days after injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle Hatton, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial ultrasound assessments for GDT in people with Acute Kidney Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Acute Kidney Injury (AKI)-Free Days (time frame: within 7 days of injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.