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Troponin T and Emergency High-risk Abdominal Surgery

7. maj 2021 opdateret af: Sofia Kärnsund, Copenhagen University Hospital, Hvidovre

Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery

To assess whether perioperatively elevated TnT levels, using high sensitivity troponin T (hsTnT) measurements, are associated with an increased risk of postoperative mortality as well as severe postoperative complications.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Cardiac Troponin T (TnT) is a cardiac-specific molecule, released into the systemic circulation following myocardial cell injury. The release of cardiac Troponins is common during critical illness and is associated with increased morbidity and mortality. The mechanisms by which TnT is released in the blood during critical illness are not fully understood, but sepsis and inflammation are primary non-cardiac conditions during which elevated TnT levels are commonly seen. Previous research has shown that 84 percent of patients admitted to ICU had at least one elevated TnT measurement perioperatively. Patients undergoing high-risk abdominal surgery, defined as immediate emergency laparoscopy or laparotomy, are critically ill, often septic and with an acute inflammatory response and potential multiple organ system dysfunctions both prior but largely after surgery.

The hypothesis is that there is an association between elevated perioperative levels of cardiac Troponin T and mortality in patients undergoing emergency high-risk abdominal surgery.

The primary objective is to assess whether perioperatively elevated TnT levels, using high sensitivity troponin T (hsTnT) measurements, are associated with an increased risk of postoperative mortality as well as severe postoperative complications.

Patients requiring immediate emergency laparotomy or laparoscopy, including reoperations after elective gastrointestinal surgery and reoperations after previous non emergency high-risk abdominal surgery surgery, will be included in the study.

Two primary exposure measures will be investigated:

  1. Peak Troponin T values ≥14 vs. Troponin T values <14. Patients with at least one measured Troponin T value ≥14 postoperatively will be allocated to the "elevated hsTnT" group
  2. Postoperative hsTnT concentration ≥14 as well as a >50% relative increase from preoperative hsTnT concentration. Patients with hsTnT levels meeting these conditions will be allocated to the "elevated hsTnT" group hsTnT will be taken by blood samples preoperatively as well as on postoperative day 1, 2 and 3.

Primary analyses investigating the association between hsTnT and 30-day mortality (yes/no) and severe complications (yes/no) will be done using logistic regression models.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

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Studiekontakt

Studiesteder

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

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

All patients undergoing emergency high-risk abdominal surgery at Hvidovre Hospital, Denmark, that meet the criteria for inclusion. Hvidovre hospital serves as the primary emergency hospital for more than 500 000 inhabitants.

Beskrivelse

Inclusion Criteria:

Adults (18 years or over) undergoing emergency laparotomy or laparoscopy for following abdominal pathology:

  • Intestinal obstruction
  • Perforated viscus
  • Intestinal ischemia
  • Intraabdominal bleeding

The above conditions include both primary surgery and re-operation after elective surgery.

Exclusion Criteria:

Patients undergoing

  • Appendicectomies
  • Negative laparoscopies/laparotomies
  • Cholecystectomies
  • Simple herniotomies following incarceration without bowel resection
  • Reoperation due to fascial separation with no other abdominal pathology identified
  • Internal hernia after Roux-en-Y gastric bypass surgery
  • Subacute surgery (surgery planned within 48 h) for inflammatory bowel diseases
  • Subacute colorectal cancer surgery
  • Patients with missing hsTnT values on both postoperative day 1 and 2

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Emergency high-risk abdominal surgery
Patients undergoing emergency high-risk abdominal surgery, defined as immediate emergency laparoscopy or laparotomy, including intestinal obstruction, perforated viscus, intestinal ischemia and intraabdominal bleeding. Includes both primary surgery and re-operation after elective surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Død
Tidsramme: 30 dage
30 dage
Severe complication (Clavien Dindo ≥ 3)
Tidsramme: 30 days
30 days

Sekundære resultatmål

Resultatmål
Tidsramme
Længde af hospitalsophold
Tidsramme: 30 dage
30 dage
Død
Tidsramme: 90 dage
90 dage
Længde af intensivophold
Tidsramme: 30 dage
30 dage

Samarbejdspartnere og efterforskere

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

Sponsor

Copenhagen University Hospital, Hvidovre

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)

1. marts 2021

Primær færdiggørelse (Forventet)

31. marts 2022

Studieafslutning (Forventet)

31. juli 2022

Datoer for studieregistrering

Først indsendt

4. maj 2021

Først indsendt, der opfyldte QC-kriterier

4. maj 2021

Først opslået (Faktiske)

7. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-21012302

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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