Trial Outcomes & Findings for Ultrasound of the Inferior Vena Cava (IVC) and Dehydration Status in Pediatric Emergency Patients (NCT NCT00267644)
NCT ID: NCT00267644
Last Updated: 2013-07-03
Results Overview
Maximum Inferior Vena Cava diameter in mm
Recruitment status
COMPLETED
Target enrollment
76 participants
Primary outcome timeframe
10 minutes
Results posted on
2013-07-03
Participant Flow
Patients were recruited from the Pediatric ED from
NO patient was excluded from the trial
Participant milestones
| Measure |
Cases
Dehydrated Pediatric Patients
|
Controls
Hydrated Pediatric Patients
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
63
|
|
Overall Study
COMPLETED
|
13
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound of the Inferior Vena Cava (IVC) and Dehydration Status in Pediatric Emergency Patients
Baseline characteristics by cohort
| Measure |
Cases
n=13 Participants
|
Controls
n=63 Participants
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
76 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
|
|
Age Continuous
|
1.6 years
STANDARD_DEVIATION .83 • n=99 Participants
|
1.2 years
STANDARD_DEVIATION .41 • n=107 Participants
|
1.5 years
STANDARD_DEVIATION .83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
63 participants
n=107 Participants
|
76 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 10 minutesMaximum Inferior Vena Cava diameter in mm
Outcome measures
| Measure |
Cases
n=13 Participants
Pediatric Patients who were dehydrated
|
Controls
n=63 Participants
Pediatric Patients that were hydrated
|
|---|---|---|
|
Maximum IVC Diameter
|
38 mm
Interval 20.0 to 84.0
|
64 mm
Interval 23.0 to 112.0
|
SECONDARY outcome
Timeframe: 10 minutesMinimum Inferior Vena Cava Diameter in mm
Outcome measures
| Measure |
Cases
n=13 Participants
Pediatric Patients who were dehydrated
|
Controls
n=63 Participants
Pediatric Patients that were hydrated
|
|---|---|---|
|
Minimum IVC Diameter
|
30 mm
Interval 3.0 to 57.0
|
45 mm
Interval 13.0 to 90.0
|
Adverse Events
Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eitan Dickman, MD; Principal Investigator
Maimonides Medical Center
Phone: 718-283-6057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place