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

Completed

• Conditions: Sepsis; Critically Ill

• Registration Number: NCT01708772
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Study Start: 2012-11
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TNF-a determination using ELISA.	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

Name	Time	Method
Evaluation of SOFA score:	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.

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Algharbiya, Egypt