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Surgery--ComplicationsPHASENCT03482830

Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery

An observational study of Surgery--Complications and Acute Illness, 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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Major emergency gastrointestinal surgery
Type of treatment
Surgery or procedure
How many people
98 participants
Where
1 siteDenmark
Study dates
5 Mar 2018to 1 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 ≥ 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.

Who may be able to join

  • 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)

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Surgery, Zealand University Hospital

    Køge, 2300

Other trials in Denmark

About this study

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.

Being tested
Major emergency gastrointestinal surgery
Keywords
Inflammation, Insulin-glucose homeostasis, Hypothalamic-pituitary-adrenal axis, Endothelial function and damage, Thyroid hormones
Medical subject headings
Gastrointestinal Diseases, Inflammation

What participants receive

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

  • Major emergency gastrointestinal surgeryProcedure or 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

What is being measured

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

  1. Changes of immunological biomarkers

    Assessment of:

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

    Measured: Change from preoperative levels at postoperative day 5

  2. Number of patients with stress induced hyperglycemia

    Assessment of:

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

    Measured: Postoperative day 5

  3. Changes of plasma thyroid hormones

    Assessment of:

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

    Measured: Change from preoperative levels at postoperative day 5

  4. Changes of the central endocrine stress response

    Assessment of plasma corticotropin releasing hormone (CRH)

    Measured: Change from preoperative levels at postoperative day 5

  5. Changes of sE-selectin

    Assessment of plasma sE-selectine

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

    Measured: Change from preoperative levels at postoperative day 5

  6. Changes of the endothelial function

    Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index

    Measured: Change from postoperative day 1 at postoperative day 5

  7. Changes of the periferal endocrine stress response

    Assessment of plasma adrenocorticotropic hormone (ACTH)

    Measured: Change from preoperative levels at postoperative day 5

  8. Changes of cortisol

    Assessment of plasma cortisol (free and bound)

    Measured: Change from preoperative levels at postoperative day 5

  9. Changes of neuropeptides

    Assessment of plasma neuropeptides

    Measured: Change from preoperative levels at postoperative day 5

  10. Changes of syndecan-1

    Assessment of plasma syndecan-1

    Measured: Change from preoperative levels at postoperative day 5

  11. Changes of thrombomodulin

    Assessment of plasma thrombomodulin

    Measured: Change from preoperative levels at postoperative day 5

  12. Changes of sVE-cadherin

    Assessment of plasma sVE-cadherin

    Measured: Change from preoperative levels at postoperative day 5

Secondary outcomes (2)

  1. Number of patients with major adverse cardiovascular events

    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

    Measured: 365 days after surgery

  2. Number of patients with postoperative non-cardiovascular complications

    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

    Measured: 365 days after surgery

Timeline

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

  1. First posted29 Mar 2018
  2. Study start5 Mar 2018
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 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
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03482830
Sponsor's protocol ID
PHASE
Acronym
PHASE
Status last verified
Jan 2020
First submitted
13 Feb 2018
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huddart S, Peden CJ, Swart M, McCormick B, Dickinson M, Mohammed MA, Quiney N; ELPQuiC Collaborator Group; ELPQuiC Collaborator Group. Use of a pathway quality improvement care bundle to reduce mortality after emergency laparotomy. Br J Surg. 2015 Jan;102(1):57-66. doi: 10.1002/bjs.9658. Epub 2014 Nov 10.

    PubMed 25384994

  • Lord JM, Midwinter MJ, Chen YF, Belli A, Brohi K, Kovacs EJ, Koenderman L, Kubes P, Lilford RJ. The systemic immune response to trauma: an overview of pathophysiology and treatment. Lancet. 2014 Oct 18;384(9952):1455-65. doi: 10.1016/S0140-6736(14)60687-5. Epub 2014 Oct 17.

    PubMed 25390327

  • Preiser JC, Ichai C, Orban JC, Groeneveld AB. Metabolic response to the stress of critical illness. Br J Anaesth. 2014 Dec;113(6):945-54. doi: 10.1093/bja/aeu187. Epub 2014 Jun 26.

    PubMed 24970271

  • Marik PE, Bellomo R. Stress hyperglycemia: an essential survival response! Crit Care Med. 2013 Jun;41(6):e93-4. doi: 10.1097/CCM.0b013e318283d124. No abstract available.

    PubMed 23685597

  • Hassan-Smith Z, Cooper MS. Overview of the endocrine response to critical illness: how to measure it and when to treat. Best Pract Res Clin Endocrinol Metab. 2011 Oct;25(5):705-17. doi: 10.1016/j.beem.2011.04.002.

    PubMed 21925072

  • Gibbison B, Angelini GD, Lightman SL. Dynamic output and control of the hypothalamic-pituitary-adrenal axis in critical illness and major surgery. Br J Anaesth. 2013 Sep;111(3):347-60. doi: 10.1093/bja/aet077. Epub 2013 May 9.

    PubMed 23661405

  • Munzel T, Sinning C, Post F, Warnholtz A, Schulz E. Pathophysiology, diagnosis and prognostic implications of endothelial dysfunction. Ann Med. 2008;40(3):180-96. doi: 10.1080/07853890701854702.

    PubMed 18382884

  • Ekeloef S, Larsen MH, Schou-Pedersen AM, Lykkesfeldt J, Rosenberg J, Gogenur I. Endothelial dysfunction in the early postoperative period after major colon cancer surgery. Br J Anaesth. 2017 Feb;118(2):200-206. doi: 10.1093/bja/aew410.

    PubMed 28100523

  • McIlroy DR, Chan MT, Wallace SK, Symons JA, Koo EG, Chu LC, Myles PS. Automated preoperative assessment of endothelial dysfunction and risk stratification for perioperative myocardial injury in patients undergoing non-cardiac surgery. Br J Anaesth. 2014 Jan;112(1):47-56. doi: 10.1093/bja/aet354. Epub 2013 Oct 29.

    PubMed 24172055

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery--Complications and Acute Illness, 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 2 inclusion and 9 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 22 Jan 2020. 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?

Changes of immunological biomarkers (time frame: Change from preoperative levels at postoperative day 5). The study lists 12 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 NCT03482830, which also lists 9 linked publications.

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 22 Jan 2020.

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