Trial Outcomes & Findings for Orthostatic Hypotension in Rehabilitation Patients (NCT NCT00117585)

Results Overview

Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

341 participants

Primary outcome timeframe

Last three blood pressures prior to discharge

Results posted on

2016-04-18

Participant Flow

341 subjects were recruited. These subjects were recruited from all admits to the rehabilitation unit.

Exclusion criteria included subjects who: couldn't stand, were admitted for respite, and were anticipated to only be on station for less than 7 days.

Participant milestones

Participant milestones
Measure	Arm 1 Stepped intervention consisting of three treatment phases Treatment 1 : Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist Treatment 2 : Fludrocortisone Salt tablets Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center
Overall Study STARTED	341
Overall Study COMPLETED	341
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Orthostatic Hypotension in Rehabilitation Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=341 Participants Stepped intervention consisting of three treatment phases Treatment 1 : Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist Treatment 2 : Fludrocortisone Salt tablets Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	341 Participants n=5 Participants
Age, Continuous	75 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	300 Participants n=5 Participants
Region of Enrollment United States	341 participants n=5 Participants

PRIMARY outcome

Timeframe: Last three blood pressures prior to discharge

Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.

Outcome measures

Outcome measures
Measure	Arm 1 n=341 Participants Stepped intervention consisting of three treatment phases Treatment 1 : Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist Treatment 2 : Fludrocortisone Salt tablets Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center
Orthostatic Hypotension at Discharge	96 participants

Adverse Events

Arm 1

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 n=341 participants at risk Stepped intervention consisting of three treatment phases Treatment 1 : Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist Treatment 2 : Fludrocortisone Salt tablets Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center
General disorders Death	1.8% 6/341

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Hickam

Portland VA Medical Center

Phone: (503) 721-7817

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place