- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04878159
Troponin T and Emergency High-risk Abdominal Surgery
Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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:
- 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
- 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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Sofia Kärnsund
- Telefonnummer: +4528261925
- E-post: sofia.paulina.kaernsund@regionh.dk
Studieorter
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Hvidovre, Danmark
- Rekrytering
- Copenhagen University Hospital Hvidovre
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Kontakt:
- Sofia Kärnsund, Medical Student
- Telefonnummer: +4528261925
- E-post: sofia.paulina.kaernsund@regionh.dk
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Kontakt:
- Mirjana Cihoric, MD
- E-post: mirjana.cihoric.03@regionh.dk
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Död
Tidsram: 30 dagar
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30 dagar
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Severe complication (Clavien Dindo ≥ 3)
Tidsram: 30 days
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30 days
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Längden på sjukhusvistelsen
Tidsram: 30 dagar
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30 dagar
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Död
Tidsram: 90 dagar
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90 dagar
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Längden på ICU-vistelsen
Tidsram: 30 dagar
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30 dagar
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-21012302
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