Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ayman Abd Al-maksoud Yousef, Tanta University
ClinicalTrials.gov Identifier:
NCT01708772
First received: October 10, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were 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 were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.


Condition
Sepsis
Critically Ill

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Tanta University:

Primary Outcome Measures:
  • TNF-a determination using ELISA. [ Time Frame: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks. ] [ Designated as safety issue: Yes ]
    A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm.


Secondary Outcome Measures:
  • Evaluation of SOFA score: [ Time Frame: Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks. ] [ Designated as safety issue: Yes ]
    SOFA score is composed of scores of six organ systems (respiratory [R], cardiovascular [C], hepatic [H], coagulation [Co], renal [Re], and neurological [N]) graded from 0 to 4 according to the degree of dysfunction/ failure.


Enrollment: 90
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sepsis
Forty five patients developed septic complication during ICU stay (sepsis group).
SIRS group
Forty five patients were critically ill without evidence of infectious organism (SIRS group).

Detailed Description:

The patients staying in ICU for more than 24 hours were enrolled in the study. 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 were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were critically ill without evidence of infectious organism (SIRS group). Patients were classified into their groups at the time of the first blood analysis for these biomarkers at ICU admission.

Criteria

Inclusion Criteria:

  • The patients staying in ICU for more than 24 hours were enrolled in the study.

Exclusion Criteria:

  • The 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 were excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708772

Locations
Egypt
Tanta university
Tanta, Algharbiya, Egypt, 35217
Sponsors and Collaborators
Tanta University
Investigators
Principal Investigator: Ayman A Yousef, MD Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
  More Information

No publications provided

Responsible Party: Ayman Abd Al-maksoud Yousef, Assistant Professor of Anesthesia, Tanta University
ClinicalTrials.gov Identifier: NCT01708772     History of Changes
Other Study ID Numbers: 1381/09/12
Study First Received: October 10, 2012
Last Updated: June 6, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Tanta University:
TNF alpha
SOFA score

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014