Correlation Between Cytokines and the Severity of Meningococcal Disease

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01133834

Collaborator

Instituto de Infectologia Emílio Ribas (Other)

100

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meningococcemia

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

100 participants

Time Perspective:

Prospective

Official Title:

Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
patients with meningococcemia Patients with meningococcemia admitted at the Intensive Care Unit

Outcome Measures

Primary Outcome Measures

shock [24 hours]
low blood pressure

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

clinical diagnostic of meningococcal disease

Exclusion Criteria:

no meningococcal disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of São Paulo General Hospital - LIM-12 and LIM-56	São Paulo		Brazil	01246-903

Sponsors and Collaborators

University of Sao Paulo General Hospital
Instituto de Infectologia Emílio Ribas

Investigators

Principal Investigator: Antonio C Seguro, MD, PhD, Hospital das Clínicas USP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01133834

Other Study ID Numbers:

meningococcemia

First Posted:

May 31, 2010

Last Update Posted:

Jun 15, 2011

Last Verified:

Feb 1, 2003

Keywords provided by , ,

meningococcal disease

cytokines

Additional relevant MeSH terms:

Meningococcal Infections

Study Results

No Results Posted as of Jun 15, 2011