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

NCT04753307 | Unknown

• 1 other identifier: INSIGHT
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Complications; Cardiovascular Complication; Myocardial Ischemia; Inflammation

Outcome Measures

Primary Outcomes (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.

  within 30 days after surgery and one year after surgery

Secondary Outcomes (10)

• C-reactive protein

  within 30 days after surgery

• Acute Kidney Injury - C-reactive proteint

  within 5 days after surgery

• Acute Kidney Injury - Interleukin 6

  within 5 days after surgery

• Acute Kidney Injury - Procalcitonin

  within 5 days after surgery

• Acute Kidney Injury - Copeptin

  within 5 days after surgery

Other Outcomes (4)

• Atrial fibrillation (AF) evaluation

  within 5 days after surgery

• SARS-Cov-2 - Inflammation

  within first 5 days after surgery

• SARS-Cov-2 - Cardiovascular Complications

  One year after surgery

Study Arms (1)

Patients at least 45 years at-risk for cardiovascular complications

Diagnostic Test: Laboratory measurements

Interventions

Laboratory measurements DIAGNOSTIC_TEST

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

Patients at least 45 years at-risk for cardiovascular complications

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• NT-proBNP ≥ 200 ng/L
• Troponin T \> 25 ng/L
• History of coronary artery disease
• History of peripheral artery disease (PAD)
• years or older
• History of transient ischemic attack (TIA) or stroke
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical University of Graz: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (5)

• 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.

  PMID: 24864079 BACKGROUND

• 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.

  PMID: 24026779 BACKGROUND

• 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.

  PMID: 28444280 BACKGROUND

• 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.

  PMID: 29146124 BACKGROUND

• 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.

  PMID: 37474184 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Myocardial Ischemia; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Christian Reiterer, MD

CONTACT

004340400; christian.reiterer@meduniwien.ac.at

Barbara Kabon, MD

CONTACT

004340400; barbara.kabon@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. univ.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 15, 2021
• Study Start: January 19, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)