Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery

NCT03010969 | Completed

• 1 other identifier: POETRY abdominal
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the clinical study is:

1. 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. 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. 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. 4.to examine the association between postoperative endothelial function, pulmonary function and blood glucose level
5. 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.

Conditions

Cardiovascular Complication; Complication, Postoperative

Keywords

Endothelial dysfunction; Surgery; Pulmonary function; Blood glucose level; Patient-related outcomes

Outcome Measures

Primary Outcomes (3)

• The change in reactive hyperemia index assessed by EndoPat

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

• 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

  Within 365 days of surgery

• 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).

  Within 365 days of surgery

Secondary Outcomes (8)

• Nitric oxide biomarkers

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

• Reactive hyperemia index assessed by EndoPat

  4-24 hours after surgery

• Reactive hyperemia index assessed by EndoPat

  between day 3 and 5 after surgery

• Blood Glucose level

  Postoperative day 1 - 7 (or until discharge)

• Pulmonary function

  Postoperative day 1 - 7 (or until discharge)

Other Outcomes (6)

• Postoperative quality of recovery (QoR15)

  postoperative day 1, 3, 5, 7, 14, 30, 90 and 365

• Numerical rating scale (NRS) pain score

  postoperative day 1, 3, 5, 7, 14, 30, 90 and 365

• Post-Traumatic Stress Disorder

  postoperative day 14, 30, 90 and 365

Interventions

Acute abdominal surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing major acute gastrointestinal surgery

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Surgery, Zealand University Hospital, Koge

Køge, 4600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32178626 DERIVED

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.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Ekeloef, MD

  Department of Surgery, Zealand University Hospital

  PRINCIPAL INVESTIGATOR

• Jakob Burcharth, MD, Phd.

  Department of Surgery, Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 5, 2017
• Study Start: October 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)