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

6. juni 2013 opdateret af: Ayman Abd Al-maksoud Yousef, Tanta University

The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring in Critically Ill Patients

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

90

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Algharbiya
      • Tanta, Algharbiya, Egypten, 35217
        • Tanta University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
TNF-a determination using ELISA.
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of SOFA score:
Tidsramme: 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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ayman A Yousef, MD, Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2012

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

10. oktober 2012

Først indsendt, der opfyldte QC-kriterier

16. oktober 2012

Først opslået (Skøn)

17. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2013

Sidst verificeret

1. juni 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1381/09/12

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sepsis

3
Abonner