- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01585909
Evaluation of Intestinal Brush Border Enzyme Function in Critically Ill Patients
28. august 2017 oppdatert av: Ulrike Holzinger, Medical University of Vienna
Evaluation of Intestinal Brush Border Enzyme Function in Patients With SIRS and Septic Shock Compared to Control Patients
The purpose of this study is to evaluate the role of several enzymes of the gut mucosa in preventing invasion of gastrointestinal bacteria.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Systemic Inflammatory Response Syndrome (SIRS), sepsis, septic shock and concomitant multiorgan failure are major causes of morbidity and mortality in intensive care units.
During SIRS and septic shock the role of the gut seems to be uncertain.
As it serves as an intestinal barrier which allows the symbiotic relationship between man and enteric bacteria, increased gut permeability during critical illness is accused to promote sepsis.
Brush border enzymes have the ability to detoxify lipopolysaccharides and prevent bacterial invasion across the gut mucosal barrier.
A reduced brush border enzyme function could contribute to the gastrointestinal intolerance in critically ill patients, which is frequently observed.
The aim of this study is to assess the influence of SIRS and septic shock on brush border enzyme morphology and function in men.
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Vienna, Østerrike, 1090
- Medical University Vienna
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Septic Shock:
Recruitment and inclusion criteria
- 15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR > 20/min, HR > 90/min, Temp. > 38°/< 36°, 12G/l< WBC < 4G/l; assumed or proven infection, persistent hypotension refractory to fluid therapy and need for vasopressors.
- Time window for inclusion: up to 72h after onset of symptoms
Exclusion criteria
- PLT < 50G/l,
- PT < 50%,
- Continuous therapeutic anticoagulation,
- DIC, st. p. MCI within 14 days,
- Gastrointestinal perforation,
- Age < 18 years,
- Age > 80 Years
SIRS:
Recruitment and inclusion criteria
- 15 mechanically ventilated critically ill patients fulfilling criteria of SIRS (2 symptoms: RR > 20/min, HR > 90/min, Temp. > 38°/< 36°, 12G/l < WBC < 4G/l; assumed or proven infection
- Time window for inclusion: up to 72h after onset of symptoms
Exclusion criteria:
- PLT < 50G/l,
- PT < 50%, continuous therapeutic anticoagulation,
- DIC, st. p. MCI within 14 days,
- Gastrointestinal perforation,
- Age < 18 years,
- Age > 80 Years
Healthy/controls:
- 15 control subjects will be recruited from the outpatient ward referred to the endoscopy of the Department of Medicine III - Division of Gastroenterology and Hepatology for upper GI-endoscopy because of epigastric pain or reflux symptoms.
Inclusion criteria:
- Signed informed consent
Exclusion criteria:
- Patients with diarrhea of unknown origin, IBD or known celiac disease
- Age < 18 years
- Age > 80 Years
- PLT < 50G/l, PT < 50%
- Therapeutic oral anticoagulation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Septic Shock
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients with septic shock
|
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
|
Annen: SIRS
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients with SIRS
|
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
|
Annen: healthy/controls
Activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as brush border morphology determined from duodenal biopsies in patients without SIRS/septic shock
|
When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
activity of the brush border membrane enzyme intestinal alkaline phosphatase
Tidsramme: at inclusion
|
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen.
Determination of enzyme activity will be done within 28 days.
|
at inclusion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
activity of the brush border membrane enzyme maltase
Tidsramme: at inclusion
|
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen.
Determination of enzyme activity will be done within 28 days.
|
at inclusion
|
activity of the brush border membrane enzyme lactase
Tidsramme: at inclusion
|
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen.
Determination of enzyme activity will be done within 28 days.
|
at inclusion
|
Brush border morphology
Tidsramme: at inclusion
|
Duodenal biopsies will be taken on day 0 (at inclusion) and will be subsequently frozen.
Determination of enzyme activity will be done within 28 days.
|
at inclusion
|
ICU mortality
Tidsramme: at ICU discharge
|
only for groups "septic shock" and "SIRS"
|
at ICU discharge
|
hospital mortality
Tidsramme: at hospital discharge
|
only for groups "septic shock" and "SIRS"
|
at hospital discharge
|
mortality (6 months)
Tidsramme: 6 months after inclusion
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6 months after inclusion
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ulrike Holzinger, MD, Medical University of Vienna
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2011
Primær fullføring (Faktiske)
1. februar 2015
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
12. april 2012
Først innsendt som oppfylte QC-kriteriene
24. april 2012
Først lagt ut (Anslag)
26. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BBM_septic_shock
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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