NCT03938038: GUIDE

Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Completed NA Results posted Last updated 26 April 2024

What this trial tests

NA trial testing Serial ultrasound assessments for GDT in Acute Kidney Injury in 415 participants. Completed in 20 July 2020.

Timeline

6 September 2019

Primary endpoint
27 June 2020

20 July 2020

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	415
Start date	6 September 2019
Primary completion	27 June 2020
Estimated completion	20 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Serial ultrasound assessments for GDT
• Usual care

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

16 and older, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Acute Kidney Injury (AKI)-Free Days Primary · 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

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	1	0 – 2
Usual Care	1	0 – 2

Number of Participants Who Receive 3 or More Ultrasound Volume Assessments Primary · within 24 hours of ICU admission

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	7
Usual Care	0

Number of Participants With Acute Kidney Injury (AKI) Secondary · 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

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	115
Usual Care	119

Stage of Acute Kidney Injury (AKI) Secondary · 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

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	67
Usual Care	64
Serial Ultrasound Assessments for GDT	32
Usual Care	37
Serial Ultrasound Assessments for GDT	16
Usual Care	18

Number of Participants With Need for Renal Replacement Therapy Secondary · within the first 30 days of ICU admission

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	16
Usual Care	18

Quantity of Fluids Administered Secondary · 24 hours

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	1562	489 – 3261
Usual Care	1471	320 – 3428

Quantity of Fluids Administered Secondary · 48 hours

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	1215	185 – 2938
Usual Care	572	281 – 1408

Quantity of Diuretics Administered Secondary · 24 hours

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	0	± 0
Usual Care	0	± 0

Quantity of Diuretics Administered Secondary · 48 hours

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	0	± 0
Usual Care	0	± 0

Number of Ventilator-free Days Secondary · within first 30 days after injury

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	29	26 – 30
Usual Care	29	26 – 30

Number of ICU-free Days Secondary · within first 30 days after injury

Group	Value	95% CI
Serial Ultrasound Assessments for GDT	26	22 – 28
Usual Care	26	22 – 28

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Serial Ultrasound Assessments for GDT

Serious: 23/222 (10%)

Deaths: 21/222

Usual Care

Serious: 15/189 (8%)

Deaths: 15/189

Serious adverse events (2 terms)

Reaction	System	Serial Ultrasound Assessme…	Usual Care
Death	General disorders	—	—
New Onset Congestive Heart Failure	Cardiac disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Serial Ultrasound Assessme…	Usual Care
Acute Kidney Injury	Renal and urinary disorders	—	—

Most-reported serious reactions: Death, New Onset Congestive Heart Failure.

Data from ClinicalTrials.gov NCT03938038 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Need for Accurate Assessment of Volume Status and Fluid Responsiveness in Critically Ill Trauma Patients: Reply to Xue and Colleagues.
   Hatton GE, Harvin JA, Wade CE, Kao LS. · · 2020 · PMID 32414685 · DOI 10.1016/j.jamcollsurg.2020.04.016