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OpenTrials
Completed

NCT Number: NCT01133834

Correlation Between Cytokines and 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.

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Key information

Conditions

Meningococcemia Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

6 month–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, 01246-903, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnostic of meningococcal disease

Exclusion criteria

  • no meningococcal disease

Treatment and study plan

Primary outcomes

  1. shock

    Time frame: 24 hours

    low blood pressure

Secondary outcomes

  1. acute kidney injury

    Time frame: 3 days

    elevation of serum creatinine levels

  2. disseminated intravascular coagulation

    Time frame: 24 hours

    plaquetopenia, coagulopathy

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Instituto de Infectologia Emílio Ribas

Registry information

Official study title

Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
May 31, 2010
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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