Correlation Between Cytokines and the Severity of Meningococcal Disease

Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

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.

Study Overview

• Status: Completed
• Conditions: Meningococcemia

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246-903
    • University of São Paulo General Hospital - LIM-12 and LIM-56

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas

Description

Inclusion Criteria:

• clinical diagnostic of meningococcal disease

Exclusion Criteria:

• no meningococcal disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with meningococcemia; Patients with meningococcemia admitted at the Intensive Care Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
shock	low blood pressure	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute kidney injury	elevation of serum creatinine levels	3 days
disseminated intravascular coagulation	plaquetopenia, coagulopathy	24 hours

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Instituto de Infectologia Emílio Ribas
• Investigators: Principal Investigator: Antonio C Seguro, MD, PhD, Hospital das Clínicas USP

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 27, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimate): May 31, 2010

Study Record Updates

• Last Update Posted (Estimate): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: February 1, 2003

More Information

Terms related to this study

• Keywords: cytokines; meningococcal disease
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: meningococcemia