- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01708772
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.
Sponsor
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
-
University of Kansas Medical CenterUniversity of KansasRekrutteringSepsis | Septisk chok | Sepsis syndrom | Sepsis, svær | Sepsis bakteriel | Sepsis BakteriæmiForenede Stater
-
Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
-
The University of QueenslandRoyal Brisbane and Women's HospitalUkendt
-
Karolinska InstitutetÖrebro University, SwedenAfsluttetSepsis | Sepsis syndrom | Sepsis, sværSverige
-
Ohio State UniversityAfsluttetSepsis, Svær Sepsis og Septisk ShockForenede Stater
-
University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Sepsis syndromDet Forenede Kongerige
-
Indonesia UniversityAfsluttetAlvorlig sepsis med septisk stød | Alvorlig sepsis uden septisk stødIndonesien
-
Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRekrutteringAlvorlig sepsis | Alvorlig sepsis uden septisk stødForenede Stater
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian... og andre samarbejdspartnereAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Infektion | Sepsis syndromForenede Stater
-
Inverness Medical InnovationsAfsluttetSepsis | Systemisk inflammatorisk responssyndrom | Alvorlig sepsis | Sepsis syndromForenede Stater