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Orthostatic Hypotension in Rehabilitation Patients
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, August 2008
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00117585
  Purpose

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.


Condition Intervention
Hypotension
Other: Treatment 1
Drug: Treatment 2
Other: Treatment 3

MedlinePlus related topics: Low Blood Pressure Rehabilitation
Drug Information available for: Sodium chloride Fludrocortisone Fludrocortisone 21-acetate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Orthostatic Hypotension in Rehabilitation Patients

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Orthostatic hypotension at discharge [ Time Frame: Last three blood pressures prior to discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 459
Study Start Date: November 2005
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Stepped intervention consisting of three treatment phases
Other: 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
Drug: Treatment 2
Fludrocortisone Salt tablets
Other: Treatment 3
Individualized treatment based on expert OH consult

Detailed Description:

This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and we expect to evaluate 459 subjects. This research program will occur over a three-year period.

Methods:

During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, we will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Admitted to Vancouver VA Nursing Home or Rehabilitation ward

Exclusion Criteria:

  • Unable to stand upon admission
  • Hospice admission
  • Respite admission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117585

Contacts
Contact: Kathleen Adams, MPH (503) 220-8262 ext 33705 kathleen.adams@va.gov
Contact: Scott L Mader (360) 690-1827 scott.mader@va.gov

Locations
United States, Oregon
VA Medical Center, Portland Recruiting
Portland, Oregon, United States, 97201
Contact: Kathleen Adams, MPH     503-220-8262 ext 33705     kathleen.adams@va.gov    
Contact: Scott L Mader     (360) 690-1827     scott.mader@va.gov    
Principal Investigator: Scott L Mader            
Sponsors and Collaborators
Investigators
Principal Investigator: Scott L Mader VA Medical Center, Portland
  More Information

Publications of Results:
Responsible Party: Department of Veterans Affairs ( Mader, Scott - Principal Investigator )
Study ID Numbers: E3616R, 01328, 05-1304
Study First Received: June 30, 2005
Last Updated: August 15, 2008
ClinicalTrials.gov Identifier: NCT00117585  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aging
Blood pressure
Hypotension
Orthostatic
Rehabilitation

Study placed in the following topic categories:
Hypotension
Postural hypotension
Hypotension, Orthostatic
Vascular Diseases
Fludrocortisone

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009