Clinical trial NCT01133834: Correlation Between Cytokines and the Severity of Meningococcal Disease
Official title: Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcemia
Keywords: meningococcal disease
cytokines
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Instituto de Infectologia Emílio Ribas
First posted: 2010-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas

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

Eligibility criteria: Inclusion Criteria:

* clinical diagnostic of meningococcal disease

Exclusion Criteria:

* no meningococcal disease

Primary outcomes:
measure: shock
timeFrame: 24 hours
Secondary outcomes:
measure: acute kidney injury
timeFrame: 3 days
measure: disseminated intravascular coagulation
timeFrame: 24 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital - LIM-12 and LIM-56
Study officials:
affiliation: Hospital das Clínicas USP
name: Antonio C Seguro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: