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Orthostatic hypotension, standing or sitting?


- candidate number23438
- NTR NumberNTR5525
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-nov-2015
- Secondary IDs15.06.95 METC
- Public TitleOrthostatic hypotension, standing or sitting?
- Scientific TitleDiagnosing orthostatic hypotension: standing versus sitting position and continuous versus interval blood pressure measurements.
- ACRONYM
- hypothesisThe aim of this observational study is to investigate a possible difference in systolic and diastolic blood pressure, cardiac output, and prevalence of orthostatic hypotension (OH) after changing positions from supine to standing versus supine to sitting. Secondary, we aim to investigate a possible difference in prevalence of OH between continuous versus interval blood pressure measurement.
- Healt Condition(s) or Problem(s) studiedOrthostatic hypotension
- Inclusion criteriaPatients age over >65 years old with a scheduled appointment at the outpatient clinic of internal medicine and a medical history of vascular disease, diabetes or hypertension.
- Exclusion criteria- When blood pressure measurements are contra-indicated because of medical reasons.
- Patients who are unable to stand without assistance.
- Patients with known peripheral vessel disease in one or both arms.
- Patients who need a large or small upper arm measurement bandage.
- Patients who are incapable of giving consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 14-dec-2015
- planned closingdate10-jun-2016
- Target number of participants100
- InterventionsBlood pressure measurements (BP) on both arms of the patient with two devices: continuous blood pressure measurements by the finometer, interval blood pressure measurements by an automated sphygmomanometer.
- Primary outcomeAn absolute difference in systolic and diastolic blood pressure, in standing versus sitting postural change.
- Secondary outcomeOrthostatic hypotension, orthostatic symptoms, cardiac output.
- TimepointsAfter scheduled appointment: BP measurements.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L.C. Hartog
- CONTACT for SCIENTIFIC QUERIESDrs. L.C. Hartog
- Sponsor/Initiator Diabetes Centre, Isala
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryOrthostatic hypotension is frequently seen in elderly people and defined by a drop in blood pressure after standing up. However, physicians sometimes decide to measure the blood pressure from supine to sitting because of mobility problems. Furthermore, automated sphygmomanometers are commonly used in daily practice, although interval blood pressure measurements may be less accurate to diagnose orthostatic hypotension. We will investigate if postural change from supine to standing versus supine to sitting or continuous versus interval blood pressure measurements,measurements changes the prevalence of orthostatic hypotension, blood pressure and cardiac output. Main outcomes are an absolute difference in systolic and diastolic blood pressure (in standing versus sitting postural change), prevalence of orthostatic hypotension, orthostatic complaints, and cardiac output.
- Main changes (audit trail)
- RECORD30-nov-2015 - 19-jan-2016


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