Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-01 @ 1:34 PM
Study NCT ID:
NCT04878159
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2021-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Troponin T and Emergency High-risk Abdominal Surgery
Sponsor:
Copenhagen University Hospital, Hvidovre
Organization:
Study Overview
Official Title:
Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: