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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
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:
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 or disease Intervention/treatment
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.

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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : November 2006

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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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


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

ClinicalTrials.gov Identifier: NCT00452712     History of Changes
Other Study ID Numbers: 156/06
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007

Keywords provided by Assaf-Harofeh Medical Center:
orthostatism
fever

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases