Trial Outcomes & Findings for Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A) (NCT NCT01116102)
NCT ID: NCT01116102
Last Updated: 2011-10-24
Results Overview
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Results posted on
2011-10-24
Participant Flow
Participant milestones
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
3
|
2
|
2
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
3
|
2
|
2
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)
Baseline characteristics by cohort
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
n=3 Participants
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
n=2 Participants
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age Continuous
|
45.9 years
n=5 Participants
|
32.6 years
n=7 Participants
|
39.6 years
n=5 Participants
|
29.3 years
n=4 Participants
|
35.4 years
n=21 Participants
|
39.7 years
n=8 Participants
|
28.2 years
n=8 Participants
|
20.9 years
n=24 Participants
|
33.3 years
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
2 participants
n=8 Participants
|
3 participants
n=24 Participants
|
20 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusionPopulation: Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion
Outcome measures
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
n=3 Participants
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
n=1 Participants
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Measured In-line Fluid Pressure
25 min
|
6.8 psi
Interval 3.1 to 10.4
|
2.4 psi
Interval 2.2 to 2.9
|
3.0 psi
Interval 2.0 to 4.1
|
8.7 psi
Interval 1.7 to 21.3
|
4.8 psi
Interval 4.3 to 5.4
|
3.2 psi
Interval 3.2 to 3.2
|
3.7 psi
Interval 3.7 to 3.8
|
6.1 psi
Interval 3.6 to 10.1
|
|
Maximum Measured In-line Fluid Pressure
35 min
|
6.5 psi
Interval 3.3 to 9.8
|
2.7 psi
Interval 1.8 to 4.0
|
2.9 psi
Interval 2.0 to 3.9
|
10.9 psi
Interval 2.3 to 19.5
|
4.5 psi
Interval 4.5 to 4.5
|
3.3 psi
Interval 3.3 to 3.3
|
4.2 psi
Interval 3.4 to 5.1
|
6.4 psi
Interval 3.6 to 12.0
|
|
Maximum Measured In-line Fluid Pressure
40 min
|
7.0 psi
Interval 3.2 to 10.9
|
2.2 psi
Interval 2.1 to 2.3
|
2.9 psi
Interval 2.0 to 3.8
|
11.5 psi
Interval 2.1 to 20.8
|
4.6 psi
Interval 4.5 to 4.6
|
3.2 psi
Interval 3.2 to 3.2
|
3.4 psi
Interval 3.4 to 3.4
|
5.9 psi
Interval 3.6 to 10.6
|
|
Maximum Measured In-line Fluid Pressure
55 min
|
5.3 psi
Interval 2.8 to 7.9
|
2.4 psi
Interval 2.2 to 2.6
|
2.9 psi
Interval 1.9 to 3.8
|
7.9 psi
Interval 2.1 to 19.0
|
4.4 psi
Interval 4.3 to 4.5
|
3.2 psi
Interval 3.2 to 3.2
|
3.4 psi
Interval 3.2 to 3.5
|
6.0 psi
Interval 3.5 to 10.9
|
|
Maximum Measured In-line Fluid Pressure
90 min
|
4.1 psi
Interval 2.9 to 5.3
|
3.6 psi
Interval 2.4 to 4.5
|
2.1 psi
Interval 1.6 to 2.7
|
4.0 psi
Interval 1.3 to 8.9
|
3.5 psi
Interval 3.0 to 4.0
|
2.7 psi
Interval 2.7 to 2.7
|
2.7 psi
Interval 2.6 to 2.8
|
7.5 psi
Interval 2.7 to 16.7
|
|
Maximum Measured In-line Fluid Pressure
105 min
|
5.0 psi
Interval 2.9 to 7.1
|
2.7 psi
Interval 2.1 to 3.2
|
2.2 psi
Interval 1.7 to 2.7
|
4.5 psi
Interval 1.2 to 10.5
|
4.0 psi
Interval 3.1 to 4.9
|
2.7 psi
Interval 2.7 to 2.7
|
2.6 psi
Interval 2.6 to 2.6
|
6.3 psi
Interval 2.7 to 13.0
|
|
Maximum Measured In-line Fluid Pressure
135 min
|
4.0 psi
Interval 3.0 to 4.9
|
2.2 psi
Interval 2.1 to 2.3
|
2.6 psi
Interval 2.3 to 2.9
|
5.0 psi
Interval 1.2 to 12.1
|
3.8 psi
Interval 2.9 to 4.7
|
2.7 psi
Interval 2.7 to 2.7
|
2.6 psi
Interval 2.6 to 2.7
|
7.4 psi
Interval 2.7 to 16.5
|
|
Maximum Measured In-line Fluid Pressure
150 min
|
2.9 psi
Interval 2.9 to 3.0
|
7.8 psi
Interval 2.3 to 18.4
|
2.0 psi
Interval 1.4 to 2.6
|
5.0 psi
Interval 1.2 to 12.2
|
3.7 psi
Interval 2.9 to 4.4
|
2.6 psi
Interval 2.6 to 2.6
|
2.6 psi
Interval 2.5 to 2.7
|
7.0 psi
Interval 2.8 to 13.4
|
|
Maximum Measured In-line Fluid Pressure
210 min
|
3.6 psi
Interval 3.1 to 4.2
|
4.0 psi
Interval 1.8 to 7.0
|
2.2 psi
Interval 1.9 to 2.4
|
4.8 psi
Interval 1.2 to 11.7
|
3.9 psi
Interval 2.9 to 4.9
|
2.8 psi
Interval 2.8 to 2.8
|
2.6 psi
Interval 2.5 to 2.7
|
6.3 psi
Interval 2.7 to 8.6
|
|
Maximum Measured In-line Fluid Pressure
240 min
|
3.2 psi
Interval 3.0 to 3.5
|
3.9 psi
Interval 1.7 to 8.0
|
2.9 psi
Interval 1.4 to 4.3
|
7.4 psi
Interval 1.2 to 10.9
|
3.4 psi
Interval 2.6 to 4.2
|
2.6 psi
Interval 2.6 to 2.6
|
2.5 psi
Interval 2.5 to 2.6
|
5.3 psi
Interval 2.6 to 9.3
|
|
Maximum Measured In-line Fluid Pressure
255 min
|
3.1 psi
Interval 2.6 to 3.6
|
4.0 psi
Interval 1.6 to 8.7
|
8.5 psi
Interval 1.3 to 15.6
|
4.8 psi
Interval 1.1 to 11.8
|
3.8 psi
Interval 2.7 to 4.8
|
2.5 psi
Interval 2.5 to 2.5
|
2.9 psi
Interval 2.7 to 3.0
|
4.9 psi
Interval 2.7 to 9.1
|
|
Maximum Measured In-line Fluid Pressure
270 min
|
3.3 psi
Interval 3.2 to 3.4
|
4.4 psi
Interval 1.7 to 9.4
|
8.8 psi
Interval 1.9 to 15.6
|
5.0 psi
Interval 1.5 to 11.9
|
3.5 psi
Interval 2.5 to 4.4
|
2.7 psi
Interval 2.7 to 2.7
|
2.5 psi
Interval 2.4 to 2.6
|
4.8 psi
Interval 2.6 to 8.8
|
|
Maximum Measured In-line Fluid Pressure
285 min
|
2.9 psi
Interval 2.8 to 3.0
|
4.9 psi
Interval 2.0 to 10.7
|
1.9 psi
Interval 1.4 to 2.5
|
4.4 psi
Interval 1.2 to 10.4
|
2.8 psi
Interval 2.5 to 3.1
|
2.5 psi
Interval 2.5 to 2.5
|
2.6 psi
Interval 2.6 to 2.6
|
4.3 psi
Interval 2.7 to 7.6
|
|
Maximum Measured In-line Fluid Pressure
1 min
|
6.9 psi
Interval 2.6 to 11.1
|
3.0 psi
Interval 2.6 to 3.5
|
6.8 psi
Interval 3.1 to 10.6
|
5.0 psi
Interval 1.5 to 11.7
|
3.8 psi
Interval 3.7 to 3.8
|
2.8 psi
Interval 2.8 to 2.8
|
1.1 psi
Interval 1.0 to 1.2
|
3.0 psi
Interval 1.5 to 5.1
|
|
Maximum Measured In-line Fluid Pressure
2 min
|
6.8 psi
Interval 2.8 to 10.8
|
2.4 psi
Interval 2.1 to 2.7
|
7.8 psi
Interval 3.3 to 12.3
|
5.9 psi
Interval 1.0 to 14.2
|
4.1 psi
Interval 3.8 to 4.4
|
3.1 psi
Interval 3.1 to 3.1
|
1.1 psi
Interval 0.9 to 1.4
|
2.4 psi
Interval 1.1 to 4.7
|
|
Maximum Measured In-line Fluid Pressure
3 min
|
6.7 psi
Interval 2.8 to 10.6
|
2.1 psi
Interval 1.9 to 2.5
|
7.4 psi
Interval 3.5 to 11.2
|
6.1 psi
Interval 1.3 to 14.9
|
4.2 psi
Interval 4.1 to 4.4
|
3.2 psi
Interval 3.2 to 3.2
|
1.2 psi
Interval 1.1 to 1.3
|
2.5 psi
Interval 1.0 to 4.9
|
|
Maximum Measured In-line Fluid Pressure
4 min
|
6.6 psi
Interval 2.8 to 10.4
|
2.1 psi
Interval 1.8 to 2.5
|
7.3 psi
Interval 3.7 to 11.0
|
6.0 psi
Interval 1.0 to 15.9
|
4.3 psi
Interval 4.3 to 4.3
|
3.2 psi
Interval 3.2 to 3.2
|
1.0 psi
Interval 1.0 to 1.1
|
2.8 psi
Interval 1.6 to 4.7
|
|
Maximum Measured In-line Fluid Pressure
5 min
|
6.1 psi
Interval 2.7 to 9.5
|
2.6 psi
Interval 1.8 to 4.1
|
9.1 psi
Interval 7.7 to 10.6
|
5.7 psi
Interval 1.0 to 15.1
|
4.4 psi
Interval 4.3 to 4.4
|
3.2 psi
Interval 3.2 to 3.2
|
1.1 psi
Interval 1.1 to 1.1
|
2.5 psi
Interval 1.1 to 4.9
|
|
Maximum Measured In-line Fluid Pressure
6 min
|
6.2 psi
Interval 2.8 to 9.6
|
3.3 psi
Interval 1.8 to 6.0
|
8.0 psi
Interval 4.9 to 11.1
|
7.1 psi
Interval 1.4 to 18.4
|
4.1 psi
Interval 4.0 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
2.2 psi
Interval 2.1 to 2.2
|
2.4 psi
Interval 2.2 to 2.5
|
|
Maximum Measured In-line Fluid Pressure
7 min
|
6.2 psi
Interval 2.8 to 9.7
|
3.2 psi
Interval 1.9 to 5.7
|
8.8 psi
Interval 3.4 to 14.1
|
7.1 psi
Interval 1.6 to 17.8
|
4.1 psi
Interval 4.1 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
2.1 psi
Interval 2.1 to 2.2
|
3.8 psi
Interval 2.2 to 6.9
|
|
Maximum Measured In-line Fluid Pressure
8 min
|
6.4 psi
Interval 2.8 to 10.1
|
3.6 psi
Interval 2.0 to 5.9
|
9.0 psi
Interval 3.7 to 14.4
|
7.3 psi
Interval 2.8 to 16.1
|
4.2 psi
Interval 4.1 to 4.3
|
3.2 psi
Interval 3.2 to 3.2
|
2.1 psi
Interval 2.1 to 2.2
|
4.6 psi
Interval 2.1 to 7.6
|
|
Maximum Measured In-line Fluid Pressure
9 min
|
6.5 psi
Interval 2.8 to 10.2
|
3.8 psi
Interval 2.0 to 6.8
|
8.2 psi
Interval 2.9 to 13.5
|
7.0 psi
Interval 2.5 to 14.5
|
4.2 psi
Interval 4.2 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
2.2 psi
Interval 2.1 to 2.3
|
4.1 psi
Interval 2.1 to 7.9
|
|
Maximum Measured In-line Fluid Pressure
10 min
|
6.5 psi
Interval 2.8 to 10.2
|
3.9 psi
Interval 1.9 to 6.7
|
7.7 psi
Interval 2.9 to 12.5
|
6.2 psi
Interval 2.4 to 12.6
|
4.1 psi
Interval 4.1 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
2.2 psi
Interval 2.1 to 2.3
|
3.9 psi
Interval 2.1 to 7.4
|
|
Maximum Measured In-line Fluid Pressure
11 min
|
6.5 psi
Interval 2.7 to 10.3
|
3.7 psi
Interval 2.0 to 6.5
|
11.9 psi
Interval 5.5 to 18.2
|
7.6 psi
Interval 2.7 to 14.5
|
4.1 psi
Interval 4.0 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
4.0 psi
Interval 3.9 to 4.0
|
6.4 psi
Interval 2.1 to 12.8
|
|
Maximum Measured In-line Fluid Pressure
12 min
|
6.7 psi
Interval 2.7 to 10.6
|
4.2 psi
Interval 1.6 to 8.9
|
13.6 psi
Interval 4.3 to 22.9
|
10.3 psi
Interval 2.2 to 21.2
|
4.1 psi
Interval 4.1 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
3.8 psi
Interval 3.7 to 3.9
|
7.4 psi
Interval 2.1 to 13.0
|
|
Maximum Measured In-line Fluid Pressure
13 min
|
6.7 psi
Interval 2.7 to 10.7
|
3.6 psi
Interval 1.7 to 7.2
|
7.7 psi
Interval 3.1 to 12.2
|
10.5 psi
Interval 2.3 to 18.8
|
4.1 psi
Interval 4.0 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
3.9 psi
Interval 3.8 to 4.0
|
7.0 psi
Interval 3.8 to 12.8
|
|
Maximum Measured In-line Fluid Pressure
14 min
|
6.6 psi
Interval 2.7 to 10.5
|
3.0 psi
Interval 1.7 to 5.2
|
3.5 psi
Interval 2.6 to 4.4
|
17.7 psi
Interval 2.1 to 34.2
|
4.1 psi
Interval 4.0 to 4.2
|
3.3 psi
Interval 3.3 to 3.3
|
3.6 psi
Interval 3.4 to 3.9
|
6.9 psi
Interval 3.8 to 11.4
|
|
Maximum Measured In-line Fluid Pressure
15 min
|
7.3 psi
Interval 3.5 to 11.0
|
4.0 psi
Interval 2.0 to 5.8
|
3.4 psi
Interval 2.6 to 4.2
|
15.8 psi
Interval 2.1 to 34.1
|
4.1 psi
Interval 4.1 to 4.2
|
3.2 psi
Interval 3.2 to 3.2
|
3.7 psi
Interval 3.5 to 3.9
|
6.5 psi
Interval 3.8 to 11.8
|
|
Maximum Measured In-line Fluid Pressure
20 min
|
7.3 psi
Interval 3.1 to 11.5
|
2.2 psi
Interval 1.7 to 3.0
|
3.3 psi
Interval 2.7 to 3.9
|
11.9 psi
Interval 1.8 to 26.3
|
4.1 psi
Interval 4.0 to 4.3
|
3.2 psi
Interval 3.2 to 3.2
|
3.6 psi
Interval 3.5 to 3.7
|
6.2 psi
Interval 3.8 to 10.9
|
|
Maximum Measured In-line Fluid Pressure
30 min
|
5.8 psi
Interval 3.3 to 8.3
|
2.2 psi
Interval 1.8 to 2.8
|
8.4 psi
Interval 2.1 to 14.8
|
8.6 psi
Interval 1.7 to 21.2
|
4.8 psi
Interval 4.8 to 4.9
|
3.2 psi
Interval 3.2 to 3.2
|
3.8 psi
Interval 3.5 to 4.0
|
5.8 psi
Interval 3.6 to 9.8
|
|
Maximum Measured In-line Fluid Pressure
45 min
|
6.6 psi
Interval 2.8 to 10.4
|
2.3 psi
Interval 2.0 to 2.6
|
2.9 psi
Interval 2.0 to 3.9
|
7.4 psi
Interval 1.7 to 18.6
|
4.3 psi
Interval 4.1 to 4.6
|
3.2 psi
Interval 3.2 to 3.2
|
3.4 psi
Interval 3.3 to 3.5
|
5.8 psi
Interval 3.6 to 10.0
|
|
Maximum Measured In-line Fluid Pressure
50 min
|
6.4 psi
Interval 2.7 to 10.0
|
2.2 psi
Interval 1.8 to 2.6
|
3.0 psi
Interval 1.9 to 4.1
|
7.8 psi
Interval 1.6 to 19.8
|
4.5 psi
Interval 4.5 to 4.5
|
3.3 psi
Interval 3.3 to 3.3
|
3.4 psi
Interval 3.3 to 3.5
|
5.8 psi
Interval 3.5 to 10.1
|
|
Maximum Measured In-line Fluid Pressure
60 min
|
5.3 psi
Interval 2.9 to 7.7
|
3.1 psi
Interval 1.9 to 4.3
|
2.9 psi
Interval 2.0 to 3.8
|
7.7 psi
Interval 1.5 to 19.3
|
3.7 psi
Interval 3.6 to 3.8
|
3.2 psi
Interval 3.2 to 3.2
|
3.4 psi
Interval 3.3 to 3.4
|
6.5 psi
Interval 3.5 to 12.2
|
|
Maximum Measured In-line Fluid Pressure
75 min
|
4.6 psi
Interval 2.6 to 6.7
|
2.6 psi
Interval 2.3 to 3.2
|
2.3 psi
Interval 1.8 to 2.8
|
5.9 psi
Interval 1.5 to 14.2
|
3.6 psi
Interval 3.0 to 4.1
|
2.8 psi
Interval 2.8 to 2.8
|
2.6 psi
Interval 2.6 to 2.7
|
7.8 psi
Interval 2.8 to 16.1
|
|
Maximum Measured In-line Fluid Pressure
120 min
|
3.4 psi
Interval 2.7 to 4.1
|
2.6 psi
Interval 1.9 to 3.6
|
2.5 psi
Interval 1.5 to 3.4
|
5.2 psi
Interval 1.2 to 12.6
|
4.3 psi
Interval 3.5 to 5.1
|
2.9 psi
Interval 2.9 to 2.9
|
2.8 psi
Interval 2.6 to 3.0
|
6.8 psi
Interval 2.7 to 14.3
|
|
Maximum Measured In-line Fluid Pressure
165 min
|
3.1 psi
Interval 2.7 to 3.4
|
2.6 psi
Interval 2.1 to 3.7
|
2.6 psi
Interval 2.4 to 2.8
|
5.0 psi
Interval 1.1 to 12.0
|
4.6 psi
Interval 4.1 to 5.1
|
2.6 psi
Interval 2.6 to 2.6
|
2.6 psi
Interval 2.5 to 2.6
|
3.4 psi
Interval 2.6 to 4.1
|
|
Maximum Measured In-line Fluid Pressure
180 min
|
3.1 psi
Interval 2.9 to 3.4
|
2.1 psi
Interval 1.8 to 2.4
|
2.1 psi
Interval 1.4 to 2.7
|
4.8 psi
Interval 1.2 to 11.5
|
3.3 psi
Interval 2.7 to 3.9
|
2.6 psi
Interval 2.6 to 2.6
|
2.6 psi
Interval 2.5 to 2.6
|
3.2 psi
Interval 2.7 to 3.5
|
|
Maximum Measured In-line Fluid Pressure
195 min
|
3.8 psi
Interval 3.0 to 4.6
|
4.0 psi
Interval 1.8 to 8.3
|
2.5 psi
Interval 1.5 to 3.4
|
5.2 psi
Interval 1.1 to 12.8
|
3.8 psi
Interval 3.1 to 4.4
|
2.6 psi
Interval 2.6 to 2.6
|
2.6 psi
Interval 2.5 to 2.8
|
3.4 psi
Interval 2.7 to 4.5
|
|
Maximum Measured In-line Fluid Pressure
225 min
|
3.4 psi
Interval 3.1 to 3.6
|
4.3 psi
Interval 1.7 to 9.1
|
1.9 psi
Interval 1.5 to 2.3
|
4.9 psi
Interval 1.1 to 12.0
|
3.1 psi
Interval 2.9 to 3.3
|
2.4 psi
Interval 2.4 to 2.4
|
2.6 psi
Interval 2.5 to 2.7
|
3.3 psi
Interval 2.7 to 4.0
|
SECONDARY outcome
Timeframe: end of catheter/needle placementPopulation: Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)
Outcome measures
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
n=3 Participants
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
n=1 Participants
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
1 attempt
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
|
Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
2 attempts
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusionPopulation: Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)
Outcome measures
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
n=3 Participants
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
n=1 Participants
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Cumulative Fluid Volume Delivered
285 min
|
998 mL
Interval 995.0 to 1000.0
|
1000 mL
Interval 998.0 to 1002.0
|
999 mL
Interval 997.0 to 1000.0
|
997 mL
Interval 997.0 to 998.0
|
999 mL
Interval 998.0 to 1000.0
|
997 mL
Interval 997.0 to 997.0
|
997 mL
Interval 997.0 to 997.0
|
996 mL
Interval 991.0 to 998.0
|
|
Cumulative Fluid Volume Delivered
5 min
|
20.8 mL
Interval 20.7 to 20.8
|
21.4 mL
Interval 20.6 to 22.2
|
4.2 mL
Interval 4.2 to 4.2
|
3.8 mL
Interval 3.1 to 4.2
|
21.1 mL
Interval 21.1 to 21.1
|
20.7 mL
Interval 20.7 to 20.7
|
4.1 mL
Interval 4.1 to 4.1
|
4.1 mL
Interval 4.1 to 4.2
|
|
Cumulative Fluid Volume Delivered
10 min
|
41.2 mL
Interval 41.2 to 41.2
|
41.3 mL
Interval 39.6 to 42.9
|
11.7 mL
Interval 11.4 to 11.9
|
11.5 mL
Interval 10.4 to 12.3
|
42.0 mL
Interval 41.9 to 42.1
|
41.2 mL
Interval 41.2 to 41.2
|
12.1 mL
Interval 12.0 to 12.1
|
11.9 mL
Interval 11.8 to 12.1
|
|
Cumulative Fluid Volume Delivered
60 min
|
250 mL
Interval 249.0 to 250.0
|
249 mL
Interval 248.0 to 250.0
|
249 mL
Interval 248.0 to 249.0
|
240 mL
Interval 228.0 to 247.0
|
249 mL
Interval 247.0 to 250.0
|
249 mL
Interval 249.0 to 249.0
|
248 mL
Interval 247.0 to 248.0
|
246 mL
Interval 243.0 to 248.0
|
|
Cumulative Fluid Volume Delivered
120 min
|
448 mL
Interval 447.0 to 449.0
|
450 mL
Interval 448.0 to 452.0
|
449 mL
Interval 447.0 to 451.0
|
447 mL
Interval 447.0 to 448.0
|
449 mL
Interval 448.0 to 450.0
|
447 mL
Interval 447.0 to 447.0
|
448 mL
Interval 446.0 to 449.0
|
446 mL
Interval 441.0 to 448.0
|
|
Cumulative Fluid Volume Delivered
180 min
|
649 mL
Interval 647.0 to 650.0
|
650 mL
Interval 648.0 to 652.0
|
649 mL
Interval 647.0 to 651.0
|
647 mL
Interval 647.0 to 648.0
|
649 mL
Interval 648.0 to 650.0
|
647 mL
Interval 647.0 to 647.0
|
650 mL
Interval 649.0 to 650.0
|
646 mL
Interval 641.0 to 648.0
|
|
Cumulative Fluid Volume Delivered
240 min
|
848 mL
Interval 847.0 to 849.0
|
850 mL
Interval 848.0 to 853.0
|
849 mL
Interval 847.0 to 851.0
|
848 mL
Interval 847.0 to 849.0
|
849 mL
Interval 848.0 to 850.0
|
847 mL
Interval 847.0 to 847.0
|
847 mL
Interval 845.0 to 848.0
|
846 mL
Interval 841.0 to 848.0
|
SECONDARY outcome
Timeframe: at any occurence of a defined challenge or at end of infusion if no challenges occurredPopulation: Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)
Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems
Outcome measures
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
n=3 Participants
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
n=1 Participants
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
n=2 Participants
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
n=3 Participants
|
|---|---|---|---|---|---|---|---|---|
|
Technical Challenges Encountered During Fluid Infusion
Occlusion Alarm
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Technical Challenges Encountered During Fluid Infusion
Intervention Needed to Secure/Maintain Infusion
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Technical Challenges Encountered During Fluid Infusion
Any Technical Challenge
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Technical Challenges Encountered During Fluid Infusion
Catheter Kinking
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
24 ga Catheter, Dose Flush, Single-step Rate Scheme
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
25 ga Needle, Dose Flush, Single-step Rate Scheme
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 ga Needle, No Dose Flush, Single-step Rate Scheme
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
24 ga Catheter, Dose Flush, Single-step Rate Scheme
n=2 participants at risk
|
24 ga Catheter, No Dose Flush, Single-step Rate Scheme
n=3 participants at risk
|
24 ga Catheter, Dose Flush, Up-titrated Rate Scheme
n=3 participants at risk
|
24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme
n=3 participants at risk
|
25 ga Needle, Dose Flush, Single-step Rate Scheme
n=2 participants at risk
|
25 ga Needle, No Dose Flush, Single-step Rate Scheme
n=2 participants at risk
|
25 ga Needle, Dose Flush, Up-titrated Rate Scheme
n=2 participants at risk
|
25 ga Needle, No Dose Flush, Up-titrated Rate Scheme
n=3 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Infusion site erythema
|
100.0%
2/2 • 7 days
|
100.0%
3/3 • 7 days
|
100.0%
3/3 • 7 days
|
100.0%
3/3 • 7 days
|
100.0%
2/2 • 7 days
|
100.0%
2/2 • 7 days
|
100.0%
2/2 • 7 days
|
100.0%
2/2 • 7 days
|
|
General disorders
Infusion site oedema
|
50.0%
1/2 • 7 days
|
66.7%
2/3 • 7 days
|
33.3%
1/3 • 7 days
|
33.3%
1/3 • 7 days
|
50.0%
1/2 • 7 days
|
0.00%
0/2 • 7 days
|
50.0%
1/2 • 7 days
|
33.3%
1/3 • 7 days
|
|
General disorders
Infusion site pain
|
100.0%
2/2 • 7 days
|
100.0%
3/3 • 7 days
|
66.7%
2/3 • 7 days
|
66.7%
2/3 • 7 days
|
100.0%
2/2 • 7 days
|
0.00%
0/2 • 7 days
|
100.0%
2/2 • 7 days
|
66.7%
2/3 • 7 days
|
|
General disorders
Infusion site pruritus
|
50.0%
1/2 • 7 days
|
0.00%
0/3 • 7 days
|
0.00%
0/3 • 7 days
|
33.3%
1/3 • 7 days
|
50.0%
1/2 • 7 days
|
0.00%
0/2 • 7 days
|
50.0%
1/2 • 7 days
|
0.00%
0/3 • 7 days
|
|
General disorders
Infusion site rash
|
50.0%
1/2 • 7 days
|
100.0%
3/3 • 7 days
|
33.3%
1/3 • 7 days
|
66.7%
2/3 • 7 days
|
50.0%
1/2 • 7 days
|
0.00%
0/2 • 7 days
|
50.0%
1/2 • 7 days
|
33.3%
1/3 • 7 days
|
|
General disorders
Infusion site swelling
|
50.0%
1/2 • 7 days
|
66.7%
2/3 • 7 days
|
66.7%
2/3 • 7 days
|
66.7%
2/3 • 7 days
|
50.0%
1/2 • 7 days
|
100.0%
2/2 • 7 days
|
50.0%
1/2 • 7 days
|
66.7%
2/3 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 7 days
|
0.00%
0/3 • 7 days
|
0.00%
0/3 • 7 days
|
0.00%
0/3 • 7 days
|
0.00%
0/2 • 7 days
|
0.00%
0/2 • 7 days
|
50.0%
1/2 • 7 days
|
33.3%
1/3 • 7 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • 7 days
|
0.00%
0/3 • 7 days
|
33.3%
1/3 • 7 days
|
0.00%
0/3 • 7 days
|
0.00%
0/2 • 7 days
|
0.00%
0/2 • 7 days
|
50.0%
1/2 • 7 days
|
0.00%
0/3 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For this study, Baxter requires a review of any planned PI results communications (eg, for confidential information) up to 30 days prior to submission or communication. Baxter may request an additional delay of up to 60 days (eg, to allow for intellectual property protection).
- Publication restrictions are in place
Restriction type: OTHER