Trial Outcomes & Findings for Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (NCT NCT00807885)
NCT ID: NCT00807885
Last Updated: 2011-10-26
Results Overview
Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
throughout subcutaneous hylenex and fluid administration period (continuous)
Results posted on
2011-10-26
Participant Flow
Participant milestones
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
|
Tape-secured 24 ga Teflon Catheter
|
Tegaderm-secured 24 ga Polyurethane Catheter
|
Tape-secured 24 ga Polyurethane Catheter
|
Tegaderm-secured 20 ga Teflon Catheter
|
Tape-secured 20 ga Teflon Catheter
|
Tegaderm-secured 20 ga Polyurethane Catheter
|
Tape-secured 20 ga Polyurethane Catheter
|
SC Button With 27 ga X 9 mm Needle
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
11
|
10
|
12
|
12
|
12
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
11
|
10
|
12
|
11
|
12
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
|
Tape-secured 24 ga Teflon Catheter
|
Tegaderm-secured 24 ga Polyurethane Catheter
|
Tape-secured 24 ga Polyurethane Catheter
|
Tegaderm-secured 20 ga Teflon Catheter
|
Tape-secured 20 ga Teflon Catheter
|
Tegaderm-secured 20 ga Polyurethane Catheter
|
Tape-secured 20 ga Polyurethane Catheter
|
SC Button With 27 ga X 9 mm Needle
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Baseline characteristics by cohort
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 Participants
|
Tape-secured 24 ga Teflon Catheter
n=11 Participants
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 Participants
|
Tape-secured 24 ga Polyurethane Catheter
n=10 Participants
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 Participants
|
Tape-secured 20 ga Teflon Catheter
n=12 Participants
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 Participants
|
Tape-secured 20 ga Polyurethane Catheter
n=11 Participants
|
SC Button With 27 ga X 9 mm Needle
n=11 Participants
|
Total
n=100 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
11 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
100 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age Continuous
|
34.6 years
STANDARD_DEVIATION 9.39 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
34.3 years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
33.6 years
STANDARD_DEVIATION 10.7 • n=115 Participants
|
32.4 years
STANDARD_DEVIATION 12.7 • n=24 Participants
|
36.6 years
STANDARD_DEVIATION 12.3 • n=42 Participants
|
34.5 years
STANDARD_DEVIATION 10.8 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
62 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
12 participants
n=21 Participants
|
12 participants
n=10 Participants
|
12 participants
n=115 Participants
|
11 participants
n=24 Participants
|
11 participants
n=42 Participants
|
100 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: throughout subcutaneous hylenex and fluid administration period (continuous)Population: ITT (all treated subjects)
Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered
Outcome measures
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 Participants
|
Tape-secured 24 ga Teflon Catheter
n=11 Participants
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 Participants
|
Tape-secured 24 ga Polyurethane Catheter
n=10 Participants
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 Participants
|
Tape-secured 20 ga Teflon Catheter
n=12 Participants
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 Participants
|
Tape-secured 20 ga Polyurethane Catheter
n=11 Participants
|
SC Button With 27 ga X 9 mm Needle
n=11 Participants
|
|---|---|---|---|---|---|---|---|---|---|
|
Technical Challenges
Subjects with No Technical Challenges
|
8 participants
|
8 participants
|
9 participants
|
8 participants
|
10 participants
|
10 participants
|
9 participants
|
9 participants
|
8 participants
|
|
Technical Challenges
Subjects with 1 TEchnical Challenge
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Technical Challenges
Subjects with at Least One Technical Challenge
|
2 participants
|
3 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
3 participants
|
|
Technical Challenges
Subjects with 2 Technical Challenges
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Technical Challenges
Subjects with 3 Technical Challenges
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Technical Challenges
Subjects with Catheter Kinking
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Technical Challenges
Subjects with Catheter Dislodgement
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Technical Challenges
Subjects with Catheter Pulled Out
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Technical Challenges
Subjects with Infusion Pump Alarm
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
|
Technical Challenges
Subjects with Infusion Pump Failure
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: from start of first attempt until completion of catheter/button placementPopulation: ITT (all treated subjects)
Outcome measures
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 Participants
|
Tape-secured 24 ga Teflon Catheter
n=11 Participants
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 Participants
|
Tape-secured 24 ga Polyurethane Catheter
n=10 Participants
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 Participants
|
Tape-secured 20 ga Teflon Catheter
n=12 Participants
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 Participants
|
Tape-secured 20 ga Polyurethane Catheter
n=11 Participants
|
SC Button With 27 ga X 9 mm Needle
n=11 Participants
|
|---|---|---|---|---|---|---|---|---|---|
|
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
1 Attempt
|
10 participants
|
11 participants
|
10 participants
|
10 participants
|
12 participants
|
11 participants
|
12 participants
|
11 participants
|
11 participants
|
|
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
2 Attempts
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: from start of first attempt until completion of catheter/button placementPopulation: ITT (all treated subjects)
Outcome measures
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 Participants
|
Tape-secured 24 ga Teflon Catheter
n=11 Participants
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 Participants
|
Tape-secured 24 ga Polyurethane Catheter
n=10 Participants
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 Participants
|
Tape-secured 20 ga Teflon Catheter
n=12 Participants
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 Participants
|
Tape-secured 20 ga Polyurethane Catheter
n=11 Participants
|
SC Button With 27 ga X 9 mm Needle
n=11 Participants
|
|---|---|---|---|---|---|---|---|---|---|
|
Time Needed to Successfully Place Subcutaneous Catheter/Button
|
23 seconds
Interval 1.0 to 39.0
|
43 seconds
Interval 2.0 to 84.0
|
30 seconds
Interval 2.0 to 63.0
|
34 seconds
Interval 10.0 to 96.0
|
30 seconds
Interval 2.0 to 58.0
|
49 seconds
Interval 2.0 to 133.0
|
31 seconds
Interval 1.0 to 90.0
|
15 seconds
Interval 1.0 to 96.0
|
9 seconds
Interval 1.0 to 47.0
|
SECONDARY outcome
Timeframe: from start of Lactated Ringer's (LR) infusion until 1000 mL LR infusedPopulation: ITT (all treated subjects)
Outcome measures
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 Participants
|
Tape-secured 24 ga Teflon Catheter
n=11 Participants
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 Participants
|
Tape-secured 24 ga Polyurethane Catheter
n=10 Participants
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 Participants
|
Tape-secured 20 ga Teflon Catheter
n=12 Participants
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 Participants
|
Tape-secured 20 ga Polyurethane Catheter
n=11 Participants
|
SC Button With 27 ga X 9 mm Needle
n=11 Participants
|
|---|---|---|---|---|---|---|---|---|---|
|
Time Required to Infuse 1000 mL Fluid
|
6.82 hours
Standard Deviation 0.058
|
6.78 hours
Standard Deviation 0.098
|
6.81 hours
Standard Deviation 0.013
|
6.80 hours
Standard Deviation 0.114
|
6.78 hours
Standard Deviation 0.071
|
6.80 hours
Standard Deviation 0.013
|
6.81 hours
Standard Deviation 0.078
|
6.79 hours
Standard Deviation 0.108
|
6.82 hours
Standard Deviation 0.078
|
Adverse Events
Tegaderm-secured 24 ga Teflon Catheter
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Tape-secured 24 ga Teflon Catheter
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Tegaderm-secured 24 ga Polyurethane Catheter
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Tape-secured 24 ga Polyurethane Catheter
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Tegaderm-secured 20 ga Teflon Catheter
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Tape-secured 20 ga Teflon Catheter
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tegaderm-secured 20 ga Polyurethane Catheter
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tape-secured 20 ga Polyurethane Catheter
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SC Button With 27 ga X 9 mm Needle
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 participants at risk
|
Tape-secured 24 ga Teflon Catheter
n=11 participants at risk
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 participants at risk
|
Tape-secured 24 ga Polyurethane Catheter
n=10 participants at risk
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 participants at risk
|
Tape-secured 20 ga Teflon Catheter
n=12 participants at risk
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 participants at risk
|
Tape-secured 20 ga Polyurethane Catheter
n=11 participants at risk
|
SC Button With 27 ga X 9 mm Needle
n=11 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
calculus ureteric
|
0.00%
0/10 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
0.00%
0/10 • 6 d post-treatment
|
8.3%
1/12 • 6 d post-treatment
|
0.00%
0/12 • 6 d post-treatment
|
0.00%
0/12 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
Other adverse events
| Measure |
Tegaderm-secured 24 ga Teflon Catheter
n=10 participants at risk
|
Tape-secured 24 ga Teflon Catheter
n=11 participants at risk
|
Tegaderm-secured 24 ga Polyurethane Catheter
n=11 participants at risk
|
Tape-secured 24 ga Polyurethane Catheter
n=10 participants at risk
|
Tegaderm-secured 20 ga Teflon Catheter
n=12 participants at risk
|
Tape-secured 20 ga Teflon Catheter
n=12 participants at risk
|
Tegaderm-secured 20 ga Polyurethane Catheter
n=12 participants at risk
|
Tape-secured 20 ga Polyurethane Catheter
n=11 participants at risk
|
SC Button With 27 ga X 9 mm Needle
n=11 participants at risk
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Infusion site erythema
|
30.0%
3/10 • 6 d post-treatment
|
18.2%
2/11 • 6 d post-treatment
|
36.4%
4/11 • 6 d post-treatment
|
20.0%
2/10 • 6 d post-treatment
|
16.7%
2/12 • 6 d post-treatment
|
25.0%
3/12 • 6 d post-treatment
|
16.7%
2/12 • 6 d post-treatment
|
36.4%
4/11 • 6 d post-treatment
|
27.3%
3/11 • 6 d post-treatment
|
|
General disorders
Infusion site pain
|
20.0%
2/10 • 6 d post-treatment
|
36.4%
4/11 • 6 d post-treatment
|
36.4%
4/11 • 6 d post-treatment
|
30.0%
3/10 • 6 d post-treatment
|
50.0%
6/12 • 6 d post-treatment
|
75.0%
9/12 • 6 d post-treatment
|
66.7%
8/12 • 6 d post-treatment
|
72.7%
8/11 • 6 d post-treatment
|
27.3%
3/11 • 6 d post-treatment
|
|
General disorders
Infusion site swelling
|
0.00%
0/10 • 6 d post-treatment
|
9.1%
1/11 • 6 d post-treatment
|
9.1%
1/11 • 6 d post-treatment
|
20.0%
2/10 • 6 d post-treatment
|
25.0%
3/12 • 6 d post-treatment
|
33.3%
4/12 • 6 d post-treatment
|
25.0%
3/12 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
9.1%
1/11 • 6 d post-treatment
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
9.1%
1/11 • 6 d post-treatment
|
0.00%
0/10 • 6 d post-treatment
|
8.3%
1/12 • 6 d post-treatment
|
8.3%
1/12 • 6 d post-treatment
|
0.00%
0/12 • 6 d post-treatment
|
18.2%
2/11 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • 6 d post-treatment
|
9.1%
1/11 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
30.0%
3/10 • 6 d post-treatment
|
8.3%
1/12 • 6 d post-treatment
|
16.7%
2/12 • 6 d post-treatment
|
0.00%
0/12 • 6 d post-treatment
|
0.00%
0/11 • 6 d post-treatment
|
18.2%
2/11 • 6 d post-treatment
|
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 90 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