Clinical Trials Directory

Trials / Completed

CompletedNCT01133834

Correlation Between Cytokines and the Severity of Meningococcal Disease

Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
University of Sao Paulo General Hospital · Academic / Other
Sex
All
Age
6 Months – 75 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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

Conditions

Timeline

Start date
2003-03-01
Primary completion
2011-06-01
Completion
2011-06-01
First posted
2010-05-31
Last updated
2011-06-15

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01133834. Inclusion in this directory is not an endorsement.