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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

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

      • 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
6 months after inclusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

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

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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