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Postoperative ComplicationsINSIGHTNCT04753307

Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery

An observational study of Postoperative Complications and Cardiovascular Complication, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Laboratory measurements
How many people
1,400 participants
Where
1 siteAustria
Study dates
19 Jan 2021to 31 Jan 2025
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients at least 45 years and at-risk to develop postoperative cardiovascular complications undergoing noncardiac surgery.

Who may be able to join

  • NT-proBNP ≥ 200 ng/L
  • Troponin T > 25 ng/L
  • History of coronary artery disease
  • History of peripheral artery disease (PAD)
  • 75 years or older
  • History of transient ischemic attack (TIA) or stroke
Show all 11Show fewer
  • Current smoking or cessation of smoking within 2 years
  • Diabetes or currently taking anti-diabetic drug
  • Hyperlipidemia
  • History of hypertension or currently taking an antihypertensive drug
  • Atrial fibrillation

Who cannot join

  • Patients on immune-suppressive therapy
  • ICU patients undergoing surgery
  • Preoperative Sepsis/systemic inflammatory syndrome (SIRS) needing ICU treatment
  • Preoperative hemodynamically instable patients, who require vasopressor or inotropic support
  • History of severe heart failure (defined as left ventricular ejection fraction (LVEF) < 30%)
  • Liver cirrhosis
  • Chronic inflammatory bowel diseases (CIBD)
  • Severe rheumatic diseases requiring immunosuppressive treatment

Trial locations and contacts

1 site in 1 country.

Christian Reiterer, MD contact

004340400 ext. 20760

christian.reiterer@meduniwien.ac.at

Barbara Kabon, MD contact

004340400 ext. 41020

barbara.kabon@meduniwien.ac.at

Austria1 site, 1 recruiting

  • Medical University of Vienna

    Vienna, 1090

    Christian Reiterer, MD, 004340400 ext. 20760, christian.reiterer@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery - a Prospective Non-interventional Observational Study

Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Therefore, we will evaluate as our primary aim the association between patients with increased postoperative inflammation, assessed with C-reactive protein measurements, and the occurrence of major cardiovascular complications after noncardiac surgery. We will further evaluate the influence of perioperative inflammation on the occurrence of postoperative acute kidney injury. We will also evaluate the association between inflammation and the influence on Days-At-Home within 30 days. Furthermore, we will evaluate the association between increased inflammatory biomarkers and postoperative N-terminal pro brain natriuretic peptide (NT-proBNP) concentration.

Being tested
Laboratory measurements
Medical subject headings
Postoperative Complications, Myocardial Ischemia, Inflammation

What participants receive

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

  • Laboratory measurementsDiagnostic test

    Inflammatory and cardiac biomarkers will be measured before surgery, and on the first, second, third and fifth postoperative day

Study groups in NCT04753307
Study groupRoleWhat they receive
Patients at least 45 years at-risk for cardiovascular complicationsNot described
Receives: Diagnostic Test: Laboratory measurements

What is being measured

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

  1. Composite of cardiovascular complications

    The primary aim of the study is to investigate the influence of the maximum C-reactive protein value (over the first 3 days after surgery) on the incidence of major cardiovascular complications within 30 days after surgery. The composite binary endpoint is defined as myocardial infarction, myocardial injury after noncardiac surgery, new onset of atrial fibrillation, stroke or death.

    Measured: within 30 days after surgery and one year after surgery

Secondary outcomes (10)

  1. C-reactive protein

    Secondary goals of the study are to investigate the influence of the C-reactive protein on day 5 on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).

    Measured: within 30 days after surgery

  2. Acute Kidney Injury - C-reactive proteint

    We will evaluate the influence C-reactive protein on the occurrence of postoperative acute kidney injury.

    Measured: within 5 days after surgery

  3. Acute Kidney Injury - Interleukin 6

    We will evaluate the influence of Interleukin 6 on the occurrence of postoperative acute kidney injury.

    Measured: within 5 days after surgery

  4. Acute Kidney Injury - Procalcitonin

    We will evaluate the influence of Procalcitonin on the occurrence of postoperative acute kidney injury.

    Measured: within 5 days after surgery

  5. Acute Kidney Injury - Copeptin

    We will evaluate the influence of Copeptin on the occurrence of postoperative acute kidney injury.

    Measured: within 5 days after surgery

  6. Days at home within 30 days (DAH 30)

    We will evaluate the correlation between perioperative inflammation (C-reactive protein, Interleukin 6, Procalcitonin, Copeptin) and the number of days patient spend at home after surgery within 30 days (DAH30). Outcomes measure: Hospital discharge data will be used to calculate hospital length of stay. DAH30 will be calculated using mortality and hospitalization data from the date of the index surgery (day 0).

    For example, if a patient will die on day 2 after surgery, they were assigned 0 DAH30. If a patient will be discharged from hospital at day 6 after surgery but will be readmitted for 4 days before the second hospital discharge, we will assign 20 DAH30. If a patient will die within 30 days after surgery, irrespective of whether they will spend time at home, DAH30 will be scored as 0.

    Measured: within 30 days after surgery

  7. NT-proBNP

    We will evaluate the correlation of each of the following inflammatory parameters including C-reactive protein, Interleukin 6, Procalcitonin, Copeptin on postoperative NT-proBNP concentration. NT-proBNP will be measured before surgery, and on the first, second and third postoperative day.

    Measured: within 5 days after surgery

  8. Interleukin 6

    We investigate the influence of the Interleukin 6 ,measured within the first five days after surgery, on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).

    Measured: within 30 days after surgery

  9. Copeptin

    We investigate the influence of the copeptin ,measured within the first five days after surgery, on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).

    Measured: within 30 days after surgery

  10. Procalcitonin

    We investigate the influence of the procalcitonin ,measured within the first five days after surgery, on the incidence of cardiovascular complications within 30 days after surgery (combined binary endpoint).

    Measured: within 30 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 posted15 Feb 2021
  2. Study start19 Jan 2021
  3. Primary completion31 Jan 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

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
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753307
Sponsor's protocol ID
INSIGHT
Acronym
INSIGHT
Status last verified
Aug 2023
First submitted
3 Feb 2021
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ridker PM, Luscher TF. Anti-inflammatory therapies for cardiovascular disease. Eur Heart J. 2014 Jul 14;35(27):1782-91. doi: 10.1093/eurheartj/ehu203. Epub 2014 May 26.

    PubMed 24864079

  • Kaptoge S, Seshasai SR, Gao P, Freitag DF, Butterworth AS, Borglykke A, Di Angelantonio E, Gudnason V, Rumley A, Lowe GD, Jorgensen T, Danesh J. Inflammatory cytokines and risk of coronary heart disease: new prospective study and updated meta-analysis. Eur Heart J. 2014 Mar;35(9):578-89. doi: 10.1093/eurheartj/eht367. Epub 2013 Sep 10.

    PubMed 24026779

  • Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

    PubMed 28444280

  • Ridker PM, MacFadyen JG, Everett BM, Libby P, Thuren T, Glynn RJ; CANTOS Trial Group. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial. Lancet. 2018 Jan 27;391(10118):319-328. doi: 10.1016/S0140-6736(17)32814-3. Epub 2017 Nov 13.

    PubMed 29146124

  • Pichler A, Kurz A, Eichlseder M, Graf A, Eichinger M, Taschner A, Kabon B, Fleischmann E, Reiterer C; INSIGHT study group. PerIoperative iNflammatory reSponse assessment In hiGH-risk patienTs undergoing non-cardiac surgery (INSIGHT): study protocol of a prospective non-interventional observational study. BMJ Open. 2023 Jul 19;13(7):e065469. doi: 10.1136/bmjopen-2022-065469.

    PubMed 37474184

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications and Cardiovascular Complication, run by Medical University of Vienna at 1 site in Austria.

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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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 Austria. 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?

Results are not available in the source record.

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

Contact Christian Reiterer, MD (004340400 ext. 20760, christian.reiterer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of cardiovascular complications (time frame: within 30 days after surgery and one year after surgery). 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 NCT04753307, which also lists 5 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 14 Aug 2023.

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