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Cardiovascular ComplicationPOETRYabdNCT03010969

Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery

An observational study of Cardiovascular Complication and Complication, Postoperative, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the clinical study is: 1. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and major adverse cardiovascular events including myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal surgery. 2. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acute abdominal surgery
Type of treatment
Surgery or procedure
How many people
224 participants
Where
1 siteDenmark
Study dates
Oct 2016to Nov 2019
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing major acute gastrointestinal surgery

Who may be able to join

  • ≥ 18 years old
  • Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
  • Major gastrointestinal surgery on the gastrointestinal tract. This will include
  • Open, laparoscopic, or laparoscopically-assisted procedures
  • Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
  • Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
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  • Washout/evacuation of intra-peritoneal hematoma
  • Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
  • Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
  • Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
  • Laparoscopic/Open Adhesiolysis
  • Return to theatre for repair of fascial dehiscence
  • Any reoperation/return to theatre meeting the criteria above is included
  • If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.

Who cannot join

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial
  • If transferred directly from the operation room or recovery ward to the intensive care unit
  • Elective laparoscopy
  • Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
  • Appendectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
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  • Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
  • Non-elective hernia repair without bowel resection.
  • Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
  • Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
  • Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
  • Laparotomy/laparoscopy for esophageal pathology Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Surgery, Zealand University Hospital, Koge

    Køge, 4600

Other trials in Denmark

About this study

Official title: Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study

The aim of the clinical study is:

  1. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and major adverse cardiovascular events including myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal surgery.
  2. to examine the association between postoperative endothelial function, indirectly measured by reactive hyperemia index, and non-cardiovascular complications including non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.
  3. to examine the importance of the postoperative blood glucose level and the pulmonary function for postoperative complications and death within 30, 90 and 365 days of acute abdominal surgery.
  4. to examine the association between postoperative endothelial function, pulmonary function and blood glucose level
  5. the qualitative part of the study will examine the postoperative subjective symptoms including acute and chronic pain, quality of recovery and functional status, depressive thoughts and post-traumatic stress disorder.
Being tested
Acute abdominal surgery
Keywords
Endothelial dysfunction, Surgery, Pulmonary function, Blood glucose level, Patient-related outcomes
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute abdominal surgeryProcedure or surgery

    Acute abdominal surgery within 72 hours of admission to the department of surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in reactive hyperemia index assessed by EndoPat

    Measured: The change from 4-24 hours to between day 3 and 5 after surgery

  2. Major adverse cardiovascular events

    • Cardiovascular death
    • Myocardial injury within postoperative day 3 (definition: peak plasma cardiac troponin-I ≥ 45ng/L (99th percentile URL, 10% CV at 40ng/L))
    • Acute coronary syndrome (unstable angina pectoris, NSTEMI, STEMI)
    • Congestive heart failure
    • Stroke
    • Nonfatal cardiac arrest
    • New clinically important cardiac arrhythmia
    • Coronary revascularization procedure (PCI or CABG)
    • Sudden unexpected death

    Measured: Within 365 days of surgery

  3. Postoperative non-cardiovascular complications

    Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).

    Measured: Within 365 days of surgery

Secondary outcomes (8)

  1. Nitric oxide biomarkers

    Measured: 4-24 hours after surgery and between postoperative day 3-5

  2. Reactive hyperemia index assessed by EndoPat

    Measured: 4-24 hours after surgery

  3. Reactive hyperemia index assessed by EndoPat

    Measured: between day 3 and 5 after surgery

  4. Blood Glucose level

    Measured: Postoperative day 1 - 7 (or until discharge)

  5. Pulmonary function

    Measured: Postoperative day 1 - 7 (or until discharge)

  6. Readmission

    Measured: Readmissions within 1 year of discharge

  7. Lengths of stay

    Measured: Lengths of stay from the operation day to discharge, on average 14 days.

  8. Lengths of stay in the intensive care unit

    Measured: Lengths of stay from the operation day to discharge from hospital, on average 14 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionNov 2018
  4. Study completionNov 2019

Resources

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
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03010969
Sponsor's protocol ID
POETRY abdominal
Acronym
POETRYabd
Status last verified
Feb 2021
First submitted
16 Dec 2016
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No: We do not plan to share IPD

Publications

  • Ekeloef S, Oreskov JO, Falkenberg A, Burcharth J, Schou-Pedersen AMV, Lykkesfeldt J, Gogenur I. Endothelial dysfunction and myocardial injury after major emergency abdominal surgery: a prospective cohort study. BMC Anesthesiol. 2020 Mar 16;20(1):67. doi: 10.1186/s12871-020-00977-0.

    PubMed 32178626

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Complication and Complication, Postoperative, run by Zealand University Hospital 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 14 inclusion and 12 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: finished, as of the sponsor's last update on 17 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in reactive hyperemia index assessed by EndoPat (time frame: The change from 4-24 hours to between day 3 and 5 after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03010969, which also lists 1 linked publication.

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 17 Feb 2021.

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