Trial Outcomes & Findings for Bedside Resources to Gauge Intravascular Volume Status (NCT NCT03915587)
NCT ID: NCT03915587
Last Updated: 2023-06-29
Results Overview
Using a delta peak aortic velocity threshold of 10% (measured from CardioQ-EDM) before and after a bolus to define fluid responders (=/\>10%) from non-responders (\<10%), we will determine the performance of pre-bolus CRI reading which is an index between 0 and 1 (0=poor reserve and 1=excellent reserve) in order to predict fluid responders from non-responders. Measurements will be recorded three times with one minute between measurements and then averaged. Vital signs analyzed included heart rate, systolic blood pressure, mean arterial pressure, shock index (heart rate/systolic blood pressure), pulse pressure variability, and end-tidal carbon dioxide level. Infants were also monitored with a Compensatory Reserve Index (CRI) monitor, which provides a continuous, individual-specific, beat-to-beat estimate of central volume status, from normovolemia (CRI=1) to decompensation (CRI=0). Each variable's performance was compared using area under the receiver operator curves (AUC).
COMPLETED
NA
23 participants
Through study completion (3-4 hours)
2023-06-29
Participant Flow
Participant milestones
| Measure |
Fluid Challenge Responders
This arm was defined as those who had an increase in their peak aortic velocity of \> 15% measured by the CardioQ-Esophageal Doppler Monitor following a crystalloid bolus (10 mL/kg)
|
Fluid Challenge Non-responders
This arm was defined as those who did not have an increase in their peak aortic velocity of \> 15% measured by the CardioQ-Esophageal Doppler Monitor following a crystalloid bolus (10 mL/kg)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
16
|
|
Overall Study
COMPLETED
|
7
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bedside Resources to Gauge Intravascular Volume Status
Baseline characteristics by cohort
| Measure |
Fluid Challenge Responders
n=7 Participants
This arm was defined as those who had an increase in their peak aortic velocity of \> 15% measured by the CardioQ-Esophageal Doppler Monitor following a crystalloid bolus (10 mL/kg)
|
Fluid Challenge Non-responders
n=16 Participants
This arm was defined as those who did not have an increase in their peak aortic velocity of \> 15% measured by the CardioQ-Esophageal Doppler Monitor following a crystalloid bolus (10 mL/kg)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
16 participants
n=107 Participants
|
23 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion (3-4 hours)Population: Fluid responders vs non-fluid responders
Using a delta peak aortic velocity threshold of 10% (measured from CardioQ-EDM) before and after a bolus to define fluid responders (=/\>10%) from non-responders (\<10%), we will determine the performance of pre-bolus CRI reading which is an index between 0 and 1 (0=poor reserve and 1=excellent reserve) in order to predict fluid responders from non-responders. Measurements will be recorded three times with one minute between measurements and then averaged. Vital signs analyzed included heart rate, systolic blood pressure, mean arterial pressure, shock index (heart rate/systolic blood pressure), pulse pressure variability, and end-tidal carbon dioxide level. Infants were also monitored with a Compensatory Reserve Index (CRI) monitor, which provides a continuous, individual-specific, beat-to-beat estimate of central volume status, from normovolemia (CRI=1) to decompensation (CRI=0). Each variable's performance was compared using area under the receiver operator curves (AUC).
Outcome measures
| Measure |
Fluid Challenge Responders
n=7 Participants
This arm was defined as those who had an increase in their peak aortic velocity of \> 15% measured by the CardioQ-Esophageal Doppler Monitor following a crystalloid bolus (10 mL/kg)
|
Fluid Challenge Non-responders
n=16 Participants
This arm was defined as those who did not have an increase in their peak aortic velocity of \> 15% measured by the CardioQ-Esophageal Doppler Monitor following a crystalloid bolus (10 mL/kg)
|
|---|---|---|
|
Utility of Compensatory Reserve Index (CRI) Which Ranges From 0-1 in Order to Predict Fluid Responders From Non-responders
|
0.06 units on a scale
Standard Deviation 0.03
|
0.05 units on a scale
Standard Deviation 0.02
|
Adverse Events
Fluid Challenge Responders
Fluid Challenge Non-responders
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place