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

Inflammation Clinical Trial

— INSIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753307
• Other study ID #: INSIGHT
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: August 2023
• Source: Medical University of Vienna
• Contact: Christian Reiterer, MD
• Phone: 004340400
• Email: christian.reiterer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

All patients need to meet all of the following criteria for inclusion (1-4):

1. Surgery planned for more than two hours

2. = 45 years of age

3. Provide written informed consent AND

4. Fulfill = 1 of the following criteria (A-K)

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiovascular Complication
• Inflammation
• Ischemia
• Myocardial Ischemia
• Postoperative Complications

Intervention

Diagnostic Test:
• Laboratory measurements
Inflammatory and cardiac biomarkers will be measured before surgery, and on the first, second, third and fifth postoperative day

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atrial fibrillation (AF) evaluation	To evaluate the incidence of asymptomatic atrial fibrillation (AF) and symptomatic AF. Asymptomatic AF will be defined as irregular pulse without any clinical symptoms. Symptomatic AF will be defined as irregular pulse with one of the symptoms including racing heart, fluttering or palpitations; fatigue, shortness of breath; and lightheadedness.	within 5 days after surgery
Other	SARS-Cov-2 - Inflammation	We will evaluate the effect of having a perioperative or previous infection with Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) on postoperative inflammatory parameters including C-reactive protein, Copeptin, Interleukin 6 and Procalcitonin.	within first 5 days after surgery
Other	SARS-Cov-2 - Cardiovascular Complications	We will evaluate the effect of having a perioperative or previous infection with SARS-CoV-2 on the incidence of our composite outcome including myocardial myocardial infarction, myocardial njury after noncardiac surgery, new onset of atrial fibrillation, stroke or death.; We will evaluate the outcome one year after surgery via a telephone interview.	One year after surgery
Other	SARS-Cov-2 One Year Follow-Up	We will evaluate the effect of a perioprative or previous SARS-Cov-2 infection on the neurocognitive function one year after surgery. Therefore, we will perform the telphone Montreal Cognitive Assessment (MoCA) before surgery and one year after surgery.	One year after surgery
Primary	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	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).	within 30 days after surgery
Secondary	Acute Kidney Injury - C-reactive proteint	We will evaluate the influence C-reactive protein on the occurrence of postoperative acute kidney injury.	within 5 days after surgery
Secondary	Acute Kidney Injury - Interleukin 6	We will evaluate the influence of Interleukin 6 on the occurrence of postoperative acute kidney injury.	within 5 days after surgery
Secondary	Acute Kidney Injury - Procalcitonin	We will evaluate the influence of Procalcitonin on the occurrence of postoperative acute kidney injury.	within 5 days after surgery
Secondary	Acute Kidney Injury - Copeptin	We will evaluate the influence of Copeptin on the occurrence of postoperative acute kidney injury.	within 5 days after surgery
Secondary	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.	within 30 days after surgery
Secondary	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.	within 5 days after surgery
Secondary	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).	within 30 days after surgery
Secondary	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).	within 30 days after surgery
Secondary	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).	within 30 days after surgery