Correlation Between Cytokines and the Severity of Meningococcal Disease

Meningococcemia Clinical Trial

Official title:

Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133834
• Other study ID #: meningococcemia
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: June 14, 2011
• Start date: March 2003
• Est. completion date: June 2011

Study information

• Verified date: February 2003
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 75 Years

Eligibility

Inclusion Criteria:

• clinical diagnostic of meningococcal disease

Exclusion Criteria:

• no meningococcal disease

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Meningococcal Infections
• Meningococcemia

Locations

Country	Name	City	State
Brazil	University of São Paulo General Hospital - LIM-12 and LIM-56	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Instituto de Infectologia Emílio Ribas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shock	low blood pressure	24 hours	Yes
Secondary	acute kidney injury	elevation of serum creatinine levels	3 days	Yes
Secondary	disseminated intravascular coagulation	plaquetopenia, coagulopathy	24 hours	Yes