Trial Outcomes & Findings for Guidance of Ultrasound in Intensive Care to Direct Euvolemia (NCT NCT03938038)

NCT ID: NCT03938038

Last Updated: 2024-04-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 415 participants
• Primary outcome timeframe: within 7 days of injury
• Results posted on: 2024-04-26

Participant Flow

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.

Unit of analysis: Care Teams

Participant milestones

Measure	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	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
First Half of the Month (15 Days) STARTED	112 4	100 4
First Half of the Month (15 Days) COMPLETED	112 4	100 4
First Half of the Month (15 Days) NOT COMPLETED	0 0	0 0
Second Half of the Month (15 Days) STARTED	89 4	110 4
Second Half of the Month (15 Days) COMPLETED	89 4	110 4
Second Half of the Month (15 Days) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guidance of Ultrasound in Intensive Care to Direct Euvolemia

Baseline characteristics by cohort

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback	Total n=411 Participants Total of all reporting groups
Age, Continuous	37 years n=93 Participants	39.5 years n=4 Participants	38 years n=27 Participants
Sex: Female, Male Female	76 Participants n=93 Participants	54 Participants n=4 Participants	130 Participants n=27 Participants
Sex: Female, Male Male	146 Participants n=93 Participants	135 Participants n=4 Participants	281 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=93 Participants	36 Participants n=4 Participants	80 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	151 Participants n=93 Participants	134 Participants n=4 Participants	285 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	27 Participants n=93 Participants	19 Participants n=4 Participants	46 Participants n=27 Participants
Region of Enrollment United States	222 participants n=93 Participants	189 participants n=4 Participants	411 participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Number of Acute Kidney Injury (AKI)-Free Days	1 Days Interval 0.0 to 2.0	1 Days Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: within 24 hours of ICU admission

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Number of Participants Who Receive 3 or More Ultrasound Volume Assessments	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Number of Participants With Acute Kidney Injury (AKI)	115 Participants	119 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=115 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=119 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Stage of Acute Kidney Injury (AKI) Stage 1	67 Participants	64 Participants
Stage of Acute Kidney Injury (AKI) Stage 2	32 Participants	37 Participants
Stage of Acute Kidney Injury (AKI) Stage 3	16 Participants	18 Participants

SECONDARY outcome

Timeframe: within the first 30 days of ICU admission

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Number of Participants With Need for Renal Replacement Therapy	16 Participants	18 Participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Quantity of Fluids Administered	1562 milliliter (mL) Interval 489.0 to 3261.0	1471 milliliter (mL) Interval 320.0 to 3428.0

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Quantity of Fluids Administered	1215 milliliter (mL) Interval 185.0 to 2938.0	572 milliliter (mL) Interval 281.0 to 1408.0

SECONDARY outcome

Timeframe: 24 hours

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Quantity of Diuretics Administered	0 milliliter (mL) Standard Deviation 0	0 milliliter (mL) Standard Deviation 0

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Quantity of Diuretics Administered	0 milliliter (mL) Standard Deviation 0	0 milliliter (mL) Standard Deviation 0

SECONDARY outcome

Timeframe: within the first 7 days of ICU admission

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within the first 7 days of ICU admission

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within the first 7 days of ICU admission

Population: Data were not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within first 30 days after injury

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Number of Ventilator-free Days	29 days Interval 26.0 to 30.0	29 days Interval 26.0 to 30.0

SECONDARY outcome

Timeframe: within first 30 days after injury

Outcome measures

Measure	Serial Ultrasound Assessments for GDT n=222 Participants Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 Participants Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Number of ICU-free Days	26 days Interval 22.0 to 28.0	26 days Interval 22.0 to 28.0

Adverse Events

Serial Ultrasound Assessments for GDT

Serious events: 23 serious events

Other events: 115 other events

Deaths: 21 deaths

Usual Care

Serious events: 15 serious events

Other events: 119 other events

Deaths: 15 deaths

Serious adverse events

Measure	Serial Ultrasound Assessments for GDT n=222 participants at risk Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 participants at risk Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
General disorders Death	9.5% 21/222 • Number of events 21 • 30 days	7.9% 15/189 • Number of events 15 • 30 days
Cardiac disorders New Onset Congestive Heart Failure	0.90% 2/222 • Number of events 2 • 30 days	0.00% 0/189 • 30 days

Other adverse events

Measure	Serial Ultrasound Assessments for GDT n=222 participants at risk Serial ultrasound assessments for GDT: routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation	Usual Care n=189 participants at risk Usual care: Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
Renal and urinary disorders Acute Kidney Injury	51.8% 115/222 • 30 days	63.0% 119/189 • 30 days

Additional Information

Gabrielle Hatton, MD

The University of Texas Health Science Center at Houston

Phone: 713-500-7211

Email: gabrielle.e.hatton@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place