ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01708772
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Ayman Abd Al-maksoud Yousef, Tanta University

Brief Summary:
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 or disease
Sepsis Critically Ill

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.

Study Type : Observational
Actual Enrollment : 90 participants
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
Study Start Date : November 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
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).



Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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. ]
    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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Ferrerira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001:286(14):1754-1758. Sheeran P, Hall GM. Cytokine balance and immunosuppressive changes at cardiac surgery. Br J Anaesth 1996; 77: 129-30. Robertshaw H J, Brennan F M. Release of tumour necrosis factor a (TNF-a) by TNF a cleaving enzyme (TACE) in response to septic stimuli in vitro. Br J Anaesth 2005; 94: 222-8.

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
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Ayman Abd Al-maksoud Yousef, Tanta University:
TNF alpha
SOFA score

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes