Assessment of the Soluble Urokinase Plasminogen Activator Receptor in Non-cardiac Surgery (SPARSE)

NCT03851965 | Completed DMC

• 1 other identifier: UTHDA-AC01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In critically ill patients, the soluble urokinase plasminogen activator receptor (suPAR) level is significantly increased. suPAR is an independent prognostic marker, and the change over time correlates with organ dysfunction. suPAR is elevated and has a prognostic value in patients with systemic inflammatory response syndrome, sepsis/septic shock, burn injuries, and traumatic brain injuries. SPARSE is a prospective observational study aiming to investigate if suPAR measured preoperatively and immediately after surgery can predict the risk of future complications and post-operative mortality in adults following major non-cardiac surgery. Participants will undergo sampling of peripheral venous blood, immediately after arrival to the Operating Room and at the Post-Anesthesia Care Unit, and plasma suPAR levels will be determined. In addition to routine hemodynamic data, sublingual microvascular flow will be measured using noninvasive technology. The primary endpoint will be the presence of complications and/or admission to ICU and/or mortality within the first 60 postoperative days. Target enrollment will be 100 patients.

Conditions

Surgery--Complications

Keywords

Soluble urokinase plasminogen activator receptor; Major non-cardiac surgery; Outcome; Perioperative

Outcome Measures

Primary Outcomes (3)

• Number of participants with postoperative complications

  Number of participants with postoperative complications

  Within the first 90 postoperative days

• Number of participants admitted to Intensive Care Unit

  Number of participants admitted to Intensive Care Unit

  Within the first 60 postoperative days

• Number of deaths

  Number of deaths

  Within the first 60 postoperative days

Secondary Outcomes (5)

• Number of participants with intraoperative complications

  During surgery

• Number of participants with need for unplanned vasoactive drugs during surgery

  During surgery

• Number of participants with acute new arrhythmia during sugery

  During surgery

• Number of reintubations

  At 30 days

• Survival

  At 30 days, at 90 days, and at 1 year

Interventions

Soluble Urokinase Plasminogen Activator Receptor DIAGNOSTIC_TEST

Preoperative and postoperative determination of the Soluble Urokinase Plasminogen Activator Receptor levels in patients undergoing non-cardiac major surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients who are scheduled to undergo elective major non-cardiac surgery with expected duration ≥2 hours under general anesthesia

You may qualify if:

• All operative approaches
• Age ≥ 18 years
• American Society of Anesthesiologists' (ASA) physical status I to IV

You may not qualify if:

• Age \<18 years
• Any infection within the previous 4 weeks
• Severe liver disease
• Renal replacement therapy pre-operatively
• Previously received transplant
• Allergies
• Inflammatory disorders
• Immune system disorders
• Connective tissue disease
• Administration of opioids during the past week
• Asthma
• Obesity (BMI ≥ 30 kg m-2)
• Mental disability
• Severe psychiatric disease
• Alcohol or other abuse,

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital of Larisa, Department of Anesthesiology

Larissa, Thessaly, 41110, Greece

Location

Related Publications (5)

• Stephens RW, Nielsen HJ, Christensen IJ, Thorlacius-Ussing O, Sorensen S, Dano K, Brunner N. Plasma urokinase receptor levels in patients with colorectal cancer: relationship to prognosis. J Natl Cancer Inst. 1999 May 19;91(10):869-74. doi: 10.1093/jnci/91.10.869.

  PMID: 10340907 BACKGROUND

• Svendsen MN, Ytting H, Brunner N, Nielsen HJ, Christensen IJ. Preoperative concentrations of suPAR and MBL proteins are associated with the development of pneumonia after elective surgery for colorectal cancer. Surg Infect (Larchmt). 2006 Oct;7(5):463-71. doi: 10.1089/sur.2006.7.463.

  PMID: 17083312 BACKGROUND

• Eugen-Olsen J, Andersen O, Linneberg A, Ladelund S, Hansen TW, Langkilde A, Petersen J, Pielak T, Moller LN, Jeppesen J, Lyngbaek S, Fenger M, Olsen MH, Hildebrandt PR, Borch-Johnsen K, Jorgensen T, Haugaard SB. Circulating soluble urokinase plasminogen activator receptor predicts cancer, cardiovascular disease, diabetes and mortality in the general population. J Intern Med. 2010 Sep;268(3):296-308. doi: 10.1111/j.1365-2796.2010.02252.x. Epub 2010 May 28.

  PMID: 20561148 BACKGROUND

• Laou E, Papagiannakis N, Michou A, Ntalarizou N, Ragias D, Angelopoulou Z, Sessler DI, Chalkias A. Association between mean arterial pressure and sublingual microcirculation during major non-cardiac surgery: Post hoc analysis of a prospective cohort. Microcirculation. 2023 May;30(4):e12804. doi: 10.1111/micc.12804. Epub 2023 Mar 21.

  PMID: 36905347 DERIVED

• Chalkias A, Laou E, Kolonia K, Ragias D, Angelopoulou Z, Mitsiouli E, Kallemose T, Smith-Hansen L, Eugen-Olsen J, Arnaoutoglou E. Elevated preoperative suPAR is a strong and independent risk marker for postoperative complications in patients undergoing major noncardiac surgery (SPARSE). Surgery. 2022 Jun;171(6):1619-1625. doi: 10.1016/j.surg.2021.10.012. Epub 2021 Nov 1.

  PMID: 34736789 DERIVED

Study Officials

• Athanasios Chalkias, MD, PhD

  University of Thessaly, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor of Anesthesiology

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: February 22, 2019
• Study Start: April 15, 2019
• Primary Completion: November 4, 2020
• Study Completion: November 5, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication and for the next 6 months.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

GR (1)