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Correlation Between Cytokines and the Severity of Meningococcal Disease

This study has been completed.
Sponsor:
Collaborator:
Instituto de Infectologia Emílio Ribas
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01133834
First received: May 27, 2010
Last updated: June 14, 2011
Last verified: February 2003
History of Changes
  Purpose

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
Meningococcemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • shock [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    low blood pressure


Secondary Outcome Measures:
  • acute kidney injury [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
    elevation of serum creatinine levels

  • disseminated intravascular coagulation [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    plaquetopenia, coagulopathy


Biospecimen Retention:   None Retained

blood sample cerebral spinal fluid


Enrollment: 100
Study Start Date: March 2003
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with meningococcemia
Patients with meningococcemia admitted at the Intensive Care Unit

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

Ages Eligible for Study:   6 Months to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • clinical diagnostic of meningococcal disease

Exclusion Criteria:

  • no meningococcal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133834

Locations
Brazil
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
  More Information

No publications provided

Responsible Party: Antonio Carlos Seguro, University of São Paulo School of Medicine
ClinicalTrials.gov Identifier: NCT01133834     History of Changes
Other Study ID Numbers: meningococcemia
Study First Received: May 27, 2010
Last Updated: June 14, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
meningococcal disease
cytokines

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2013