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Orthostatic Hypotension in Children With Acute Febrile Illness
This study is currently recruiting participants.
Verified by Assaf-Harofeh Medical Center, May 2007
Sponsored by: Assaf-Harofeh Medical Center
Information provided by: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00452712
  Purpose

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.


Condition Intervention 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 II

MedlinePlus related topics: Fever Low Blood Pressure
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study

Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 100
Study Start Date: November 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Age: 4-18 year of age.
  • Oral temperature > 38.0
  • Duration of fever 6-48 hours

Exclusion Criteria:

  • Treatment with medications that may cause orthostatism.
  • Vomiting or/and diarrhea (more than twice/day).
  • Suspected CNS infection.
  • Chronic diseases
  • Unable to give an informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452712

Contacts
Contact: Tzipora Shalem, MD 972 8 9717731 shalema@zahav.net.il
Contact: Eran Kozer 972 8 9779916 erank@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Sub-Investigator: Tzipora Shalem            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Eran Kozer Assaf-Harofeh Medical Center
  More Information

Study ID Numbers: 156/06
Study First Received: March 26, 2007
Last Updated: May 2, 2007
ClinicalTrials.gov Identifier: NCT00452712  
Health Authority: Israel: Minstry of Health

Keywords provided by Assaf-Harofeh Medical Center:
orthostatism
fever

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 05, 2009