- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01708772
Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients
6 juni 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
90
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Algharbiya
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Tanta, Algharbiya, Egypten, 35217
- Tanta University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Sepsis
Forty five patients developed septic complication during ICU stay (sepsis group).
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SIRS group
Forty five patients were critically ill without evidence of infectious organism (SIRS group).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
TNF-a determination using ELISA.
Tidsram: 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.
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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.
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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.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Evaluation of SOFA score:
Tidsram: 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.
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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.
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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.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Ayman A Yousef, MD, Assistant professor os Anesthesia and ICU, Faculty of Medicine, Tanta university
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2012
Primärt slutförande (Faktisk)
1 december 2012
Avslutad studie (Faktisk)
1 januari 2013
Studieregistreringsdatum
Först inskickad
10 oktober 2012
Först inskickad som uppfyllde QC-kriterierna
16 oktober 2012
Första postat (Uppskatta)
17 oktober 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 juni 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juni 2013
Senast verifierad
1 juni 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1381/09/12
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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