Correlation Between Cytokines and the Severity of Meningococcal Disease

Completed

• Conditions: Meningococcemia

• Registration Number: NCT01133834
• Lead Sponsor: University of Sao Paulo General Hospital

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 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

Study Timeline

• Status Verified: 2003-02
• Study Start: 2003-03
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• clinical diagnostic of meningococcal disease

Exclusion Criteria

• no meningococcal disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
shock	24 hours	low blood pressure

Secondary Outcome Measures

Name	Time	Method
disseminated intravascular coagulation	24 hours	plaquetopenia, coagulopathy
acute kidney injury	3 days	elevation of serum creatinine levels

Trial Locations

Locations (1)

University of São Paulo General Hospital - LIM-12 and LIM-56; 🇧🇷 São Paulo, Brazil