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Troponin T and Emergency High-risk Abdominal Surgery

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ClinicalTrials.gov Identifier: NCT04878159
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Sofia Kärnsund, Copenhagen University Hospital, Hvidovre

Study Description
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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.

Condition or disease
Emergency Laparotomy Inflammatory Response Myocardial Injury

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : July 31, 2022
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Death [ Time Frame: 30 days ]
  2. Severe complication (Clavien Dindo ≥ 3) [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 90 days ]
  2. Length of hospital stay [ Time Frame: 30 days ]
  3. Length of ICU stay [ Time Frame: 30 days ]

Biospecimen Retention:   None Retained
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878159


Contacts
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Contact: Sofia Kärnsund +4528261925 sofia.paulina.kaernsund@regionh.dk

Locations
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Denmark
Copenhagen University Hospital Hvidovre Recruiting
Hvidovre, Denmark
Contact: Sofia Kärnsund, Medical Student    +4528261925    sofia.paulina.kaernsund@regionh.dk   
Contact: Mirjana Cihoric, MD       mirjana.cihoric.03@regionh.dk   
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
More Information
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Responsible Party: Sofia Kärnsund, Principal Investigator, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT04878159    
Other Study ID Numbers: H-21012302
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes