Orthostatic Hypotension in Children With Acute Febrile Illness
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|ClinicalTrials.gov Identifier: NCT00452712|
Recruitment Status : Unknown
Verified May 2007 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : March 27, 2007
Last Update Posted : May 3, 2007
|Condition or disease||Intervention/treatment||Phase|
|Fever Orthostatic Hypotension||Procedure: All subjects will have their blood pressure measured in supine position (after 5 minute of rest) and after 3 minute of standing.||Phase 2|
Orthosatic hypotension describes a condition in which the autonomic nervous system fails to maintain a stable blood pressure in the face of postural change. Children presenting to the pediatric ED with fever often describe symptom like syncope, lightheadedness, dizziness, pallor, fatigue and weakness. These symptom may result from orthostatism related to acute febrile illness. We assume that fever may be associated with autonomic changes (e.g. vasodilatation) that can cause orthostatism. Objective:
to determent if children suffering from acute febrile illness has higher rate of orthostatic hypotension compared with children with no febrile illness. Design: a prospective cohort study. Subjects: children aged 4-18 year with fever (temperature > 38.) for up to 48 hours, presenting to the pediatric emergency department. Interventions: All subjects will have their blood pressure measured in supine position (after 5 minute of rest) and after 3 minute of standing. Data analysis: The proportion of children with orthostatic hypotension in febrile and non febrile patients will be compared using χ2 test. The changes in blood pressure in both groups will be compared using the Student t test.
Assumption: We assumed that the incidence of orthostatism is higher among children with fever, because fever can cause orthostatism. Significance: Orthostatism can cause syncope which is a potentially dangerous symptom (e.g. head trauma). Syncope accounts for 1-3% of hospital admissions in US. The incidence in youths is estimated at about 15%) Patients presenting to the ED with syncope may undergo numerous and expensive work up with low diagnostic yield. -understanding that fever itself can cause orthostatism and syncope may help us with precaution and diagnosis.
Key word: orthostatism, fever children, emergency medicine.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Defined Population|
|Study Start Date :||November 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452712
|Contact: Tzipora Shalem, MD||972 8 firstname.lastname@example.org|
|Contact: Eran Kozer||972 8 email@example.com|
|Assaf Harofeh Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Sub-Investigator: Tzipora Shalem|
|Principal Investigator:||Eran Kozer||Assaf-Harofeh Medical Center|