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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03851965
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Athanasios Chalkias, MD, PhD, University of Thessaly

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.

Condition or disease Intervention/treatment
Surgery--Complications Diagnostic Test: Soluble Urokinase Plasminogen Activator Receptor

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study on Assessment of the Soluble Urokinase Plasminogen Activator Receptor in Adult Patients Undergoing Major Non-cardiac Surgery
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : November 4, 2020
Actual Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Soluble Urokinase Plasminogen Activator Receptor
    Preoperative and postoperative determination of the Soluble Urokinase Plasminogen Activator Receptor levels in patients undergoing non-cardiac major surgery.


Primary Outcome Measures :
  1. Number of participants with postoperative complications [ Time Frame: Within the first 90 postoperative days ]
    Number of participants with postoperative complications

  2. Number of participants admitted to Intensive Care Unit [ Time Frame: Within the first 60 postoperative days ]
    Number of participants admitted to Intensive Care Unit

  3. Number of deaths [ Time Frame: Within the first 60 postoperative days ]
    Number of deaths


Secondary Outcome Measures :
  1. Number of participants with intraoperative complications [ Time Frame: During surgery ]
    Number of participants with desaturation [SpO2 <92% for 3 minutes or more], need for unplanned recruitment maneuvers, hypotension [defined as systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg for 3 minutes or more or need of vasoactive drugs for correction]

  2. Number of participants with need for unplanned vasoactive drugs during surgery [ Time Frame: During surgery ]
    Number of participants with need for vasoactive drugs not planned before and/or continuous infusion during surgery

  3. Number of participants with acute new arrhythmia during sugery [ Time Frame: During surgery ]
    Number of participants with atrial fibrillation, sustained ventricular tachycardia, supraventricular tachycardia, and/or cardiac arrest during surgery

  4. Number of reintubations [ Time Frame: At 30 days ]
    Number of participants being reintubated after extubation

  5. Survival [ Time Frame: At 30 days, at 90 days, and at 1 year ]
    Survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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,
  • Legal incapacity or limited legal capacity
  • Subjects within the exclusion period of another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851965


Locations
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Greece
University Hospital of Larisa, Department of Anesthesiology
Larisa, Thessaly, Greece, 41110
Sponsors and Collaborators
University of Thessaly
Investigators
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Principal Investigator: Athanasios Chalkias, MD, PhD University of Thessaly, Faculty of Medicine
  Study Documents (Full-Text)

Documents provided by Athanasios Chalkias, MD, PhD, University of Thessaly:
Informed Consent Form  [PDF] December 11, 2018

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Athanasios Chalkias, MD, PhD, Asst. Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT03851965    
Other Study ID Numbers: UTHDA-AC01
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Athanasios Chalkias, MD, PhD, University of Thessaly:
Soluble urokinase plasminogen activator receptor
Major non-cardiac surgery
Outcome
Perioperative
Additional relevant MeSH terms:
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Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action