Orthostatic Hypotension in Rehabilitation Patients

NCT00117585 | Completed Results

• 1 other identifier: E3616-R
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

Conditions

Hypotension, Orthostatic

Keywords

Aging; Blood pressure; Hypotension; Orthostatic; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Orthostatic Hypotension at 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.

  Last three blood pressures prior to discharge

Study Arms (1)

Treatment Phase 1

OTHER

Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)

Other: Treatment Phase 1; Drug: Treatment Phase 2; Other: Treatment Phase 3

Interventions

Treatment Phase 1 OTHER

* Patient Education * Physical Therapy Exercises * Increased Salt Intake * Elevation of head of bed with 2-4 inch wedge * Medication Review by MD, Pharma

Treatment Phase 1

Treatment Phase 2 DRUG

Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1. * Fludrocortisone * Salt tablet

Also known as: Florinef

Treatment Phase 1

Treatment Phase 3 OTHER

Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.

Treatment Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to Vancouver VA Nursing Home or Rehabilitation ward

You may not qualify if:

• Unable to stand upon admission
• Hospice admission
• Respite admission

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic; Hypotension

Interventions

fludrocortisone acetate

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. David Hickam
• Organization: Portland VA Medical Center

david.hickam@va.gov

(503) 721-7817

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 7, 2005
• Study Start: November 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 18, 2016
• Results First Posted: July 4, 2014

Record last verified: 2016-03

Locations

US (1)