Correlation Between Cytokines and the Severity of Meningococcal Disease

NCT ID: NCT01133834

Last Updated: 2011-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2011-06-30

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

Conditions

Meningococcemia

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

patients with meningococcemia

Patients with meningococcemia admitted at the Intensive Care Unit

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• clinical diagnostic of meningococcal disease

Exclusion Criteria

• no meningococcal disease

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Infectologia Emílio Ribas

UNKNOWN

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

University of São Paulo School of Medicine

Principal Investigators

Antonio C Seguro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clínicas USP

Locations

University of São Paulo General Hospital - LIM-12 and LIM-56

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

meningococcemia

Identifier Type: -

Identifier Source: org_study_id