Serum STREM and MNDA Mointoring in ICU

NCT02120521 | Completed DMC

• 1 other identifier: 1637/02/13
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 120 patients will be included in the study. Sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

Conditions

Sepsis .

Keywords

Sepsis and SIRS, ICU

Outcome Measures

Primary Outcomes (1)

• dynamic changes of serum sTREM-1 and MNDA

  determine the dynamic changes of serum sTREM-1 and the corresponding changes of serum MNDA and their correlation in critically ill sepsis and SIRS patients.

  one week

Secondary Outcomes (1)

• Survival in critically ill sepsis and SIRS patients

  two weeks

Study Arms (2)

Sepsis group

Sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

SIRS group

Sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

120 critically ill patients, sixty patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and sixty patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of sTREM-1 and MNDA will be monitored.

You may qualify if:

• The patients staying in ICU for more than 24 hours will be included in the study.

You may not qualify if:

• Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University hospitals

Tanta, Algharbyia, 35217, Egypt

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayman A Yousef

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 22, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

EG (1)