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Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery (POETRYabd)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03010969
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sarah Victoria Ekeløf Busch, Zealand University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Cardiovascular Complication Complication, Postoperative Procedure: Acute abdominal surgery

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Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study
Study Start Date : October 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2019

Intervention Details:
  • Procedure: Acute abdominal surgery
    Acute abdominal surgery within 72 hours of admission to the department of surgery


Primary Outcome Measures :
  1. Reactive hyperemia index assessed by EndoPat [ Time Frame: 4-24 hours after surgery ]
  2. Major adverse cardiovascular events [ Time Frame: Within 365 days of surgery ]
    • 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

  3. Postoperative non-cardiovascular complications [ Time Frame: Within 365 days of surgery ]
    Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).


Secondary Outcome Measures :
  1. Blood Glucose level [ Time Frame: Postoperative day 1 - 7 (or until discharge) ]
  2. Pulmonary function [ Time Frame: Postoperative day 1 - 7 (or until discharge) ]
  3. Nitric oxide biomarkers [ Time Frame: 4-24 hours after surgery and between postoperative day 3-5 ]
  4. Readmission [ Time Frame: Readmissions within 1 year of discharge ]
  5. Lengths of stay [ Time Frame: Lengths of stay from the operation day to discharge, on average 14 days. ]
  6. Lengths of stay in the intensive care unit [ Time Frame: Lengths of stay from the operation day to discharge from hospital, on average 14 days. ]
  7. Reactive hyperemia index assessed by EndoPat [ Time Frame: between day 3 and 5 after surgery ]
  8. 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 ]

Other Outcome Measures:
  1. Postoperative quality of recovery (QoR15) [ Time Frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365 ]
    QoR15 score

  2. Numerical rating scale (NRS) pain score [ Time Frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365 ]
    NRS pain score in rest and at activity

  3. Post-Traumatic Stress Disorder [ Time Frame: postoperative day 14, 30, 90 and 365 ]
    Post-Traumatic Stress Disorder questionnaire

  4. Depressive thoughts [ Time Frame: postoperative day 14, 30, 90 and 365 ]
    Hospital anxiety and depression scale

  5. Postoperative pain [ Time Frame: postoperative day 14, 30, 90 and 365 ]
    Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)

  6. Functional status [ Time Frame: postoperative day 14, 30, 90 and 365 ]
    Activity Assessment Scale


Biospecimen Retention:   Samples With DNA

The blood will be collected from a larger vein (e.g. the cubital vein). Cardiac troponin I Tetrahydrobiopterin: Blood is sampled into 4mL EDTA tubes. Immediately after withdrawal, a minimum of 1mL blood is mixed with 25μL DTE. The mixture is centrifuged at 2000g for 5 minutes. Plasma is frozen and stored at -80°C.

Arginine and ADMA: Blood is sampled into 4mL EDTA tubes. Blood samples will be centrifuged at 3000g for 10 minutes, plasma frozen and stored at -80°C until analyzed with high performance liquid chromatography.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing major acute gastrointestinal surgery
Criteria

Inclusion criteria

  • ≥ 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)
  • 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.

Exclusion criteria

  • 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
  • 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

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): NCT03010969


Locations
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Denmark
Department of Surgery, Zealand University Hospital, Koge
Køge, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Sarah Ekeloef, MD Department of Surgery, Zealand University Hospital
Principal Investigator: Jakob Burcharth, MD, Phd. Department of Surgery, Zealand University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarah Victoria Ekeløf Busch, MD, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03010969    
Other Study ID Numbers: POETRY abdominal
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD
Keywords provided by Sarah Victoria Ekeløf Busch, Zealand University Hospital:
Endothelial dysfunction
Surgery
Pulmonary function
Blood glucose level
Patient-related outcomes
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes