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

21. januar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

98

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zealand University Hospital

Efterforskere

  • Ledende efterforsker: Jakob Burcharth, MD, PhD, Zealand University Hospital

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.

Generelle publikationer

Hjælpsomme links

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 (Faktiske)

5. marts 2018

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Faktiske)

1. november 2019

Datoer for studieregistrering

Først indsendt

13. februar 2018

Først indsendt, der opfyldte QC-kriterier

22. marts 2018

Først opslået (Faktiske)

29. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • pHase

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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