An observational study in Meningococcemia, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 6 Months to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-15.
Sponsored by University of Sao Paulo General Hospital · Observational
Objectives:
Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate the level of these cytokines to severity of MD.
Design:
Prospective, nonrandomized study.
Setting:
Tertiary referral intensive care unit.
Patients:
Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.
Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD:
IL -4; IL-6; IL-10 and interferon alfa, as well as relate the level of these cytokines to severity of MD, evaluated by occurrence of shock, acute renal failure, disseminated intravascular coagulation and survival.
Design: Prospective, nonrandomized study. Setting: Tertiary referral intensive care unit. Patients: Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.
Measurements and Main Results: in process Conclusions: in process
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 100 is close to the median of 109 across 26 observational studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas
Exclusion Criteria:
Patients with meningococcemia admitted at the Intensive Care Unit
shock
low blood pressure
Time frame: 24 hours
acute kidney injury
elevation of serum creatinine levels
Time frame: 3 days
disseminated intravascular coagulation
plaquetopenia, coagulopathy
Time frame: 24 hours
This study is completed, as verified in Feb 2003. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital