Status:
COMPLETED
Flu Vaccination in Congestive Heart Failure
Lead Sponsor:
La Fundacion Favaloro para la Investigacion y la Docencia Medica
Conditions:
Heart Failure
Eligibility:
All Genders
21-90 years
Phase:
PHASE4
Brief Summary
We evaluated the preventive impact of vaccination on subsequent death events in 117 severe congestive heart patients requiring ventilator support without endotracheal intubations and aggressive medica...
Detailed Description
Background: Recent reports detected that one of the barriers that vaccination against influenza infection is that, physicians do not strongly recommend its applications to cardiovascular patients at r...
Eligibility Criteria
Inclusion
- Male or female patient's \> 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion.
- Definite evidence of underlying heart failure was also required as shown by at least two of the following:
- a) Orthopnea on admission
- b) X-ray showing evidences of elevated wedge pressure indicating congestive heart failure
- c) recent prior hospitalization (within the 30 days prior to the index hospitalization) because a congestive heart failure episode
- d) echocardiography data showing a poor left ventricular ejection fraction (0.40 or lower measuring with the biplane Simpson's method
- e) non-invasive ventilation to the maintenance of SaO2 above 90%
- f) wet rales in at least the lower half of the lungs fields
- Patients with a final diagnosis of Congestive Heart Failure as a consequence of necrotic or chronic ischemic heart disease, or infective origin such as chronic Chagas Disease, chronic valvular heart disease (surgically repaired or not), and idiopathic origin were also included for the present study
Exclusion
- Patients with a concomitant infective disease were excluded from the study
- Patients with evidence of evolving with multi organic failure (hepatic or renal dysfunction requiring dialysis), terminal disease, or any impeding cause of follow-up, including contraindications of vaccination, were excluded from the study
- Those with congestive heart failure following unstable coronary artery disease, or prior by-pass surgery, or angioplasty or congestive heart failure complicating myocardial infarction requiring urgent intervention were excluded also
- Those individuals who required mechanical ventilation on admission
- Patients with prior vaccinations were also excluded
- Pregnancy condition was an exclusion criterion
- Those patients who were unable or refused to give a written inform consent was also excluded of the present study
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00664339
Start Date
May 1 2007
End Date
March 1 2008
Last Update
April 22 2008
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