Measurement Of NT-proBNP to Predict Outcomes in Surgery

NCT04014647 | Suspended

• 1 other identifier: 260029 (34-03-19)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The team is investigating whether N-terminal pro B-type natriuretic peptide (NT-proBNP) and other cardiac markers are useful for predicting outcomes for patients undergoing vascular surgery. By measuring NT-proBNP before and after surgery, the investigators may be able to determine which patients are at risk of an adverse outcome, such as a heart attack or death.

Conditions

Vascular Surgical Procedure

Keywords

Vascular Surgical Procedure; Pro-brain natriuretic peptide (1-76); Natriuretic Peptide, Brain; Troponin I; Galectin 3; Biomarkers; Risk

Outcome Measures

Primary Outcomes (3)

• NT-proBNP blood test measured on the day of (pre-) vascular surgery

  NT-proBNP blood test measured on the day of (pre-) vascular surgery

  4 days

• NT-proBNP blood test measured on the day 4 after (post-) vascular surgery

  NT-proBNP blood test measured on the day 4 after (post-) vascular surgery

  4 days

• Change in NT-proBNP peri-operatively

  Change in NT-proBNP peri-operatively

  4 days

Secondary Outcomes (4)

• Pre-, post-, and peri-operative troponin I

  4 days

• Pre-, post-, and peri-operative galectin-3

  4 days

• Pre-, post-, and peri-operative CRP

  4 days

• Pre-, post-, and peri-operative creatinine

  4 days

Study Arms (2)

Event-free

Patients who have had no negative events (as described in group 2)

Negative event

Group 2 - patients with one or more of the following negative events post-operatively: * Whether the patient has been prescribed inotropic support * Wound infection by assessing use of antibiotics. * Length of stay in hospital \>1 week * Reduced renal function assessed by having any AKI alert during hospital stay * Cardiac event within 31 days following surgery * Death within 31 days following surgery

Eligibility Criteria

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

Study Population

Patients who have been referred to have vascular surgery

You may qualify if:

• Patients who are equal to or over 18 years old
• Patients scheduled to undergo elective surgery for the following procedures:
• Infrainguinal arterial reconstruction
• Aortic aneurysm
• Aorto-bifemoral bypass / or aortic endarterectomy
• Femoro-popliteal bypass
• Femoro-distal bypass
• Femoral endarterectomy
• Femoro-femoral crossover
• Axillo-femoral bypass
• Elective carotid surgery
• Patients having either general or regional anaesthesia for their surgery

You may not qualify if:

• Patients undergoing emergency surgery
• Those who are unable or unwilling to give informed consent
• Patients with unstable coronary syndromes (acute or recent MI with evidence of important ischemic risk by clinical symptoms or stress testing or unstable or severe angina pectoris)
• Patients with decompensated heart failure (new onset shortness of breath and rales together with echocardiographic evidence of cardiac dysfunction or deterioration of chronic heart failure despite heart failure therapy)
• Patients with chronic atrial fibrillation

Sponsors & Collaborators

• Julie Dawson: lead

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Publications (7)

• Augoustides J, Fleisher LA. Advancing perioperative prediction of cardiac risk after vascular surgery: does postoperative N-terminal pro-brain natriuretic peptide do the trick? Anesthesiology. 2007 Jun;106(6):1080-2. doi: 10.1097/01.anes.0000267586.04132.65. No abstract available.

  PMID: 17525578 BACKGROUND

• Bursi F, Babuin L, Barbieri A, Politi L, Zennaro M, Grimaldi T, Rumolo A, Gargiulo M, Stella A, Modena MG, Jaffe AS. Vascular surgery patients: perioperative and long-term risk according to the ACC/AHA guidelines, the additive role of post-operative troponin elevation. Eur Heart J. 2005 Nov;26(22):2448-56. doi: 10.1093/eurheartj/ehi430. Epub 2005 Jul 29.

  PMID: 16055493 BACKGROUND

• Canavan M, Smyth A, Robinson SM, Gibson I, Costello C, O'Keeffe ST, Walsh T, Mulkerrin EC, O'Donnell MJ. Attitudes to outcomes measured in clinical trials of cardiovascular prevention. QJM. 2016 Jun;109(6):391-7. doi: 10.1093/qjmed/hcv132. Epub 2015 Jul 31.

  PMID: 26231089 BACKGROUND

• Feringa HH, Schouten O, Dunkelgrun M, Bax JJ, Boersma E, Elhendy A, de Jonge R, Karagiannis SE, Vidakovic R, Poldermans D. Plasma N-terminal pro-B-type natriuretic peptide as long-term prognostic marker after major vascular surgery. Heart. 2007 Feb;93(2):226-31. doi: 10.1136/hrt.2006.093716. Epub 2006 Aug 16.

  PMID: 16914484 BACKGROUND

• Mahla E, Baumann A, Rehak P, Watzinger N, Vicenzi MN, Maier R, Tiesenhausen K, Metzler H, Toller W. N-terminal pro-brain natriuretic peptide identifies patients at high risk for adverse cardiac outcome after vascular surgery. Anesthesiology. 2007 Jun;106(6):1088-95. doi: 10.1097/01.anes.0000267591.34626.b0.

  PMID: 17525582 BACKGROUND

• van Kimmenade RR, Januzzi JL Jr, Ellinor PT, Sharma UC, Bakker JA, Low AF, Martinez A, Crijns HJ, MacRae CA, Menheere PP, Pinto YM. Utility of amino-terminal pro-brain natriuretic peptide, galectin-3, and apelin for the evaluation of patients with acute heart failure. J Am Coll Cardiol. 2006 Sep 19;48(6):1217-24. doi: 10.1016/j.jacc.2006.03.061. Epub 2006 Aug 28.

  PMID: 16979009 BACKGROUND

• Yeh HM, Lau HP, Lin JM, Sun WZ, Wang MJ, Lai LP. Preoperative plasma N-terminal pro-brain natriuretic peptide as a marker of cardiac risk in patients undergoing elective non-cardiac surgery. Br J Surg. 2005 Aug;92(8):1041-5. doi: 10.1002/bjs.4947.

  PMID: 15997451 BACKGROUND

Study Officials

• Emma Miler, MSc BSc Hons

  principle investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Services Manager

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: September 5, 2019
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)