Orthostatic Hypotension in Children With Acute Febrile Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00452712
First received: March 26, 2007
Last updated: May 2, 2007
Last verified: May 2007
  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 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Assaf-Harofeh Medical Center:
orthostatism
fever

Additional relevant MeSH terms:
Hypotension, Orthostatic
Fever
Hypotension
Body Temperature Changes
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014