Trial Outcomes & Findings for Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension (NCT NCT01520207)
NCT ID: NCT01520207
Last Updated: 2019-01-30
Results Overview
SBP decline during first three sessions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
First three hemodialysis sessions (5 days)
Results posted on
2019-01-30
Participant Flow
July 2012 - Jul 2016
Participant milestones
| Measure |
Placebo Group: (0.9% Normal Saline)
0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
|
Intervention: Intravenous Mannitol (20%)
Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
Baseline characteristics by cohort
| Measure |
Placebo Group: (0.9% Normal Saline)
n=27 Participants
0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
|
Intervention: Intravenous Mannitol (20%)
n=25 Participants
Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 17.4 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First three hemodialysis sessions (5 days)Population: SBP decline
SBP decline during first three sessions
Outcome measures
| Measure |
Placebo Group: (0.9% Normal Saline)
n=27 Participants
0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
|
Intervention: Intravenous Mannitol (20%)
n=25 Participants
Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
|
|---|---|---|
|
Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
|
19 mmHg
Standard Deviation 16
|
15 mmHg
Standard Deviation 11
|
Adverse Events
Placebo Group: (0.9% Normal Saline)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Intervention: Intravenous Mannitol (20%)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Group: (0.9% Normal Saline)
n=27 participants at risk
0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
|
Intervention: Intravenous Mannitol (20%)
n=25 participants at risk
Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.
Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Cramps
|
7.4%
2/27 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
4.0%
1/25 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Cardiac disorders
Hypertension
|
37.0%
10/27 • Number of events 15 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
36.0%
9/25 • Number of events 15 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Cardiac disorders
Hypotension
|
7.4%
2/27 • Number of events 4 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
8.0%
2/25 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Nervous system disorders
Headache
|
7.4%
2/27 • Number of events 3 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
4.0%
1/25 • Number of events 1 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Gastrointestinal disorders
Nausea
|
18.5%
5/27 • Number of events 5 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
4.0%
1/25 • Number of events 1 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Infections and infestations
UTI
|
0.00%
0/27 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
4.0%
1/25 • Number of events 1 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Vascular disorders
Access issues
|
7.4%
2/27 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
8.0%
2/25 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen Requirement
|
7.4%
2/27 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
16.0%
4/25 • Number of events 7 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/27 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
8.0%
2/25 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Nervous system disorders
Confusion
|
7.4%
2/27 • Number of events 2 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
4.0%
1/25 • Number of events 1 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
4.0%
1/25 • Number of events 1 • 4 years
Adverse events were monitored for all participants during their HD sessions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place