Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Acute Kidney Injury Clinical Trial

— GUIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938038
• Other study ID #: HSC-MS-19-0425
• Status: Completed
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: July 20, 2020
• Est. primary completion date: June 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Injured patients that are admitted to the trauma ICU

Exclusion Criteria:

• Incarceration

• Pregnancy

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	within 7 days of injury
Primary	Number of Participants Who Receive 3 or More Ultrasound Volume Assessments		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	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	within the first 7 days of ICU admission
Secondary	Number of Participants With Need for Renal Replacement Therapy		within the first 30 days of ICU admission
Secondary	Quantity of Fluids Administered		24 hours
Secondary	Quantity of Fluids Administered		48 hours
Secondary	Type of Fluids Administered		24 hours
Secondary	Type of Fluids Administered		48 hours
Secondary	Quantity of Diuretics Administered		24 hours
Secondary	Quantity of Diuretics Administered		48 hours
Secondary	Time to Lactate Normalization		within the first 7 days of ICU admission
Secondary	Time to Creatinine Concentration <1.5 mg/dL or to Prehospital Baseline		within the first 7 days of ICU admission
Secondary	Time to Base Excess Normalization		within the first 7 days of ICU admission
Secondary	Number of Ventilator-free Days		within first 30 days after injury
Secondary	Number of ICU-free Days		within first 30 days after injury