Trial Outcomes & Findings for An Open Label Trial to Decrease Signs and Symptoms of Orthostatic Hypotension Using Midodrine or Intravenous Fluid Bolus in Patients Following Total Hip Arthroplasty (NCT NCT02154243)
NCT ID: NCT02154243
Last Updated: 2017-07-31
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)
Results posted on
2017-07-31
Participant Flow
Participant milestones
| Measure |
Midodrine
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session
|
Intravenous Fluid Bolus
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session
|
Control (no Intervention)
Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Midodrine
n=5 Participants
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session
|
Intravenous Fluid Bolus
n=4 Participants
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session
|
Control (no Intervention)
n=4 Participants
Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
57.7 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
55.9 years
STANDARD_DEVIATION 11.2 • n=13 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
13 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)Population: DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.
Outcome measures
| Measure |
Midodrine
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session
|
Intravenous Fluid Bolus
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session
|
Control (no Intervention)
Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
|
|---|---|---|---|
|
Change in Orthostatic Hypotension Questionnaire Score
|
0
|
0
|
0
|
SECONDARY outcome
Timeframe: Length of the hospital stay (average of 4 days)Population: DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.
Outcome measures
| Measure |
Midodrine
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\<15 will be given oral midodrine, 10 mg, once.
Midodrine: 10 mg, p.o., once, on day of surgery after first physical therapy session
|
Intravenous Fluid Bolus
Patients who are diagnosed with orthostatic hypotension at their first physical therapy session and have an SVV\>=15 will be given intravenous fluid bolus, 15 cc/kg, once.
Intravenous fluid bolus: 15 cc/kg, once, on day of surgery after first physical therapy session
|
Control (no Intervention)
Patients who are NOT diagnosed with orthostatic hypotension at their first physical therapy session will be given the interventions.
|
|---|---|---|---|
|
Length of Stay
|
0
|
0
|
0
|
Adverse Events
Midodrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Fluid Bolus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (no Intervention)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place