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

NCT ID: NCT01708772

Last Updated: 2013-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis Critically Ill

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis

Forty five patients developed septic complication during ICU stay (sepsis group).

No interventions assigned to this group

SIRS group

Forty five patients were critically ill without evidence of infectious organism (SIRS group).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Abd Al-maksoud Yousef

Assistant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman A Yousef, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university

Locations

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Tanta university

Tanta, Algharbiya, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND

Other Identifiers

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1381/09/12

Identifier Type: -

Identifier Source: org_study_id

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