Clinical Trial: Correlation Between Cytokines and the Severity of Meningococcal Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

Brief 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 Summary:

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


Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: shock [ Time Frame: 24 hours ]

low blood pressure


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • acute kidney injury [ Time Frame: 3 days ]
    elevation of serum creatinine levels
  • disseminated intravascular coagulation [ Time Frame: 24 hours ]
    plaquetopenia, coagulopathy


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: May 27, 2010
Date Started: March 2003
Date Completion:
Last Updated: June 14, 2011
Last Verified: February 2003