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Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery (PHASE)

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ClinicalTrials.gov Identifier: NCT03482830
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:

Emergency laparotomies, which most often is performed due to high risk disease (bowel obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency surgical departments, however, give rise to 80 % of all postoperative complications. The 30-day mortality rates in relation to these emergent procedures have been reported between 14-30 %, with even higher numbers for frail and older patients. The specific reasons for these outcomes are not yet known, however, a combination of preexisting comorbidities, acute illness, sepsis, and the surgical stress response that arise during- and after the surgical procedure due to the activation of the immunological and humoral system, is most likely to blame. The complex endocrinological response and consequences of this response to emergency surgery are sparsely reported in the literature.

The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial and immunological changes after major emergency abdominal surgery, and to associate these changes with clinical postoperative outcomes.


Condition or disease Intervention/treatment
Surgery--Complications Acute Illness Gastrointestinal Disease Stress Procedure: Major emergency gastrointestinal surgery

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2019

Intervention Details:
  • Procedure: Major emergency gastrointestinal surgery
    • 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


Primary Outcome Measures :
  1. Changes of immunological biomarkers [ Time Frame: Change from preoperative levels at postoperative day 5 ]

    Assessment of:

    • plasma inflammatory interleukines incl. IL-1-alfa, IL-1beta, IL-6, IL-10
    • plasma TNF-alfa
    • plasma TGF-beta

  2. Number of patients with stress induced hyperglycemia [ Time Frame: Postoperative day 5 ]

    Assessment of:

    • Blood glucose, plasma c-peptide, HbA1C
    • plasma Glucagon-like peptide 1 (GLP-1)

  3. Changes of plasma thyroid hormones [ Time Frame: Change from preoperative levels at postoperative day 5 ]

    Assessment of:

    • Thyropin-releasing hormone (TRH)
    • Thyroid-stimulating hormone (TSH)
    • Thyroid hormones (fT3, fT4, rT3)

  4. Changes of the central endocrine stress response [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma corticotropin releasing hormone (CRH)

  5. Changes of sE-selectin [ Time Frame: Change from preoperative levels at postoperative day 5 ]

    Assessment of plasma sE-selectine

    • sE-selectin
    • syndecan-1
    • thrombomodulin
    • sVE-cadherin

  6. Changes of the endothelial function [ Time Frame: Change from postoperative day 1 at postoperative day 5 ]
    Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index

  7. Changes of the periferal endocrine stress response [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma adrenocorticotropic hormone (ACTH)

  8. Changes of cortisol [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma cortisol (free and bound)

  9. Changes of neuropeptides [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma neuropeptides

  10. Changes of syndecan-1 [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma syndecan-1

  11. Changes of thrombomodulin [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma thrombomodulin

  12. Changes of sVE-cadherin [ Time Frame: Change from preoperative levels at postoperative day 5 ]
    Assessment of plasma sVE-cadherin


Secondary Outcome Measures :
  1. Number of patients with major adverse cardiovascular events [ Time Frame: 365 days after surgery ]

    Defined as:

    • Cardiovascular death
    • Myocardial injury within postoperative day 4 (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

  2. Number of patients with postoperative non-cardiovascular complications [ Time Frame: 365 days after surgery ]

    Defined as:

    • Non-cardiovascular death with other defined reason for death
    • Sepsis (sepsis - severe sepsis - septic shock)
    • Pneumonia
    • Respiratory failure
    • Surgical complications (Clavien-Dindo stage 3)
    • Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4)
    • Readmission due to a non-cardiovascular complication


Biospecimen Retention:   Samples With DNA
Plasma, whole blood


Information from the National Library of Medicine

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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 ≥ 18 years old undergoing acute major gastrointestinal surgery within 72 hours of their admission to the Department of Surgery or an acute reoperation.

Major gastrointestinal surgery are defined as procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction.

Patients will be consecutively screened for inclusion.

Criteria

Inclusion Criteria:

  • Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
  • Major gastrointestinal surgery on the gastrointestinal tract (see intervention definition)

Exclusion Criteria:

  • Not capable of giving informed consent after oral and written information
  • Previously included in the trial
  • 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 or Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
  • 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, esophageal pathology, 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): NCT03482830


Locations
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Denmark
Department of Surgery, Zealand University Hospital
Køge, Denmark, 2300
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Jakob Burcharth, MD, PhD Zealand University Hospital

Additional Information:
Publications:

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03482830    
Other Study ID Numbers: PHASE
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Inflammation
Insulin-glucose homeostasis
Hypothalamic-pituitary-adrenal axis
Endothelial function and damage
Thyroid hormones
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Emergencies
Digestive System Diseases
Disease Attributes
Pathologic Processes