Emergency LaparotomyNCT04878159
Troponin T and Emergency High-risk Abdominal Surgery
An observational study of Emergency Laparotomy and Inflammatory Response, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Laparotomy, Inflammatory Response, Myocardial Injury
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 31 Jul 2022
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Hvidovre
Hvidovre
Sofia Kärnsund, Medical Student, +4528261925, sofia.paulina.kaernsund@regionh.dk
Mirjana Cihoric, MD, mirjana.cihoric.03@regionh.dk
About this study
Official title: 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.
Read the 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:
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 30 days
Severe complication (Clavien Dindo ≥ 3)
Measured: 30 days
Secondary outcomes (3)
Death
Measured: 90 days
Length of hospital stay
Measured: 30 days
Length of ICU stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Kärnsund, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878159
- Sponsor's protocol ID
- H-21012302
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04878159
- Acronym / sponsor ID
- H-21012302
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Adults (18 years or over) undergoing emergency laparotomy or laparoscopy for following abdominal pathology:
- Intestinal obstruction
- Perforated viscus
- Intestinal ischemia
- Intraabdominal bleeding
Key exclusion criteria (10 listed)
- Patients undergoing
- Appendicectomies
- Negative laparoscopies/laparotomies
- Cholecystectomies
- Simple herniotomies following incarceration without bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death
Time frame: 30 days
Severe complication (Clavien Dindo ≥ 3)
Time frame: 30 days
3 secondary outcomes
Death
Time frame: 90 days
Length of hospital stay
Time frame: 30 days
Length of ICU stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Laparotomy and Inflammatory Response, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Kärnsund (+4528261925, sofia.paulina.kaernsund@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.