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Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery (PHASE)

21. januar 2020 oppdatert av: Zealand University Hospital

Emergency laparotomies, which most often is performed due to high risk disease (bowel obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency surgical departments, however, give rise to 80 % of all postoperative complications. The 30-day mortality rates in relation to these emergent procedures have been reported between 14-30 %, with even higher numbers for frail and older patients. The specific reasons for these outcomes are not yet known, however, a combination of preexisting comorbidities, acute illness, sepsis, and the surgical stress response that arise during- and after the surgical procedure due to the activation of the immunological and humoral system, is most likely to blame. The complex endocrinological response and consequences of this response to emergency surgery are sparsely reported in the literature.

The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial and immunological changes after major emergency abdominal surgery, and to associate these changes with clinical postoperative outcomes.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

98

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Køge, Danmark, 2300
        • Department of Surgery, Zealand University Hospital

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Patients ≥ 18 years old undergoing acute major gastrointestinal surgery within 72 hours of their admission to the Department of Surgery or an acute reoperation.

Major gastrointestinal surgery are defined as procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction.

Patients will be consecutively screened for inclusion.

Beskrivelse

Inclusion Criteria:

  • Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
  • Major gastrointestinal surgery on the gastrointestinal tract (see intervention definition)

Exclusion Criteria:

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial
  • Elective laparoscopy
  • Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
  • Appendectomy +/- drainage or Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
  • Non-elective hernia repair without bowel resection.
  • Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
  • Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
  • Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma, esophageal pathology, pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes of immunological biomarkers
Tidsramme: Change from preoperative levels at postoperative day 5

Assessment of:

  • plasma inflammatory interleukines incl. IL-1-alfa, IL-1beta, IL-6, IL-10
  • plasma TNF-alfa
  • plasma TGF-beta
Change from preoperative levels at postoperative day 5
Number of patients with stress induced hyperglycemia
Tidsramme: Postoperative day 5

Assessment of:

  • Blood glucose, plasma c-peptide, HbA1C
  • plasma Glucagon-like peptide 1 (GLP-1)
Postoperative day 5
Changes of plasma thyroid hormones
Tidsramme: Change from preoperative levels at postoperative day 5

Assessment of:

  • Thyropin-releasing hormone (TRH)
  • Thyroid-stimulating hormone (TSH)
  • Thyroid hormones (fT3, fT4, rT3)
Change from preoperative levels at postoperative day 5
Changes of the central endocrine stress response
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma corticotropin releasing hormone (CRH)
Change from preoperative levels at postoperative day 5
Changes of sE-selectin
Tidsramme: Change from preoperative levels at postoperative day 5

Assessment of plasma sE-selectine

  • sE-selectin
  • syndecan-1
  • thrombomodulin
  • sVE-cadherin
Change from preoperative levels at postoperative day 5
Changes of the endothelial function
Tidsramme: Change from postoperative day 1 at postoperative day 5
Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index
Change from postoperative day 1 at postoperative day 5
Changes of the periferal endocrine stress response
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma adrenocorticotropic hormone (ACTH)
Change from preoperative levels at postoperative day 5
Changes of cortisol
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma cortisol (free and bound)
Change from preoperative levels at postoperative day 5
Changes of neuropeptides
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma neuropeptides
Change from preoperative levels at postoperative day 5
Changes of syndecan-1
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma syndecan-1
Change from preoperative levels at postoperative day 5
Changes of thrombomodulin
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma thrombomodulin
Change from preoperative levels at postoperative day 5
Changes of sVE-cadherin
Tidsramme: Change from preoperative levels at postoperative day 5
Assessment of plasma sVE-cadherin
Change from preoperative levels at postoperative day 5

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of patients with major adverse cardiovascular events
Tidsramme: 365 days after surgery

Defined as:

  • Cardiovascular death
  • Myocardial injury within postoperative day 4 (definition: peak plasma cardiac troponin-I ≥ 45ng/L (99th percentile URL, 10% CV at 40ng/L))
  • Acute coronary syndrome (unstable angina pectoris, NSTEMI, STEMI)
  • Congestive heart failure
  • Stroke
  • Nonfatal cardiac arrest
  • New clinically important cardiac arrhythmia
  • Coronary revascularization procedure (PCI or CABG)
  • Sudden unexpected death
365 days after surgery
Number of patients with postoperative non-cardiovascular complications
Tidsramme: 365 days after surgery

Defined as:

  • Non-cardiovascular death with other defined reason for death
  • Sepsis (sepsis - severe sepsis - septic shock)
  • Pneumonia
  • Respiratory failure
  • Surgical complications (Clavien-Dindo stage 3)
  • Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4)
  • Readmission due to a non-cardiovascular complication
365 days after surgery

Samarbeidspartnere og etterforskere

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

Sponsor

Zealand University Hospital

Etterforskere

  • Hovedetterforsker: Jakob Burcharth, MD, PhD, Zealand University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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 (Faktiske)

5. mars 2018

Primær fullføring (Faktiske)

1. november 2018

Studiet fullført (Faktiske)

1. november 2019

Datoer for studieregistrering

Først innsendt

13. februar 2018

Først innsendt som oppfylte QC-kriteriene

22. mars 2018

Først lagt ut (Faktiske)

29. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. januar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PHASE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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