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Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management

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ClinicalTrials.gov Identifier: NCT03527758
Recruitment Status : Not yet recruiting
First Posted : May 17, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Giovanni Li Volti
Marinella Astuto
Francesco Vasile
Gaetano Joseph Palumbo
Mirko Mineri
Christian Bonsignore
Salvatore Pennisi
Carmelo Minardi
Bruno Lanzafame
Luigi Lavia
Veronica Dezio
Information provided by (Responsible Party):
Paolo Murabito, University of Catania

Brief Summary:

Intraoperative hypotension (defined as mean arterial pressure below 65 mmHg) is associated with increased organs dysfunction and mortality. Even short durations of reduced arterial blood pressure episodes significantly increased the risk of myocardial injury, neurological deficits, renal failure, and mortality. Hypotension rate during surgery is quite common and recent studies showed an incidence up to 60% of patients endured hypotension during anesthesia for an average of 10% of surgical time.

Nowadays hypotension seems to be preventable even if current management of the hypotensive episodes is predominantly reactive and rather occurs with some delay.

The investigators hypothesize that the prevention of hypotension by means Edwards Lifesciences new technology (HPI software) can improve patients outcome after surgery.

The present pilot randomized clinical trial is aimed at investigating various biomarkers involved in organ dysfunction and how they correlate with different intraoperative hypotension management strategies (Invasive blood pressure monitored by a normal arterial line vs Invasive blood pressure monitored by Edwards FloTracIQ system with HPI software).


Condition or disease Intervention/treatment Phase
Hypotension Brain Injuries Renal Failure Endothelial Dysfunction Device: Flo TracIQ with HPI software Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Invasive intraoperative monitoring
Experimental: Flo TracIQ with HPI software Device: Flo TracIQ with HPI software
Patients will be monitored intraoperatively with Flo TracIQ with HPI software in order to predict hypotensive events. Blood sample will be obtained in order to evaluate ealy organ dysfunction.




Primary Outcome Measures :
  1. Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury. [ Time Frame: 2 hours after starting anesthesia ]
    The following biomarkers will be assessed: neuron specific enolase and S100B (for brain monitoring); high sensitive cardiac troponin T (for heart monitoring); Neutrophil Gelatinase-Associated Lipocalin (NGAL, for kidney monitoring); circulating endothelial cells counting and cytofluorimetric analysis (for endothelial monitoring).Systemic effects of intraoperative hypotension will be determine by measuring inflammatory cytokines (IL-6, IL-1 beta and TNF-alfa), oxidative stress biomarkers (reduced glutathione, lipid hydroperoxides) and markers of hypoxia (HIF1alpha, lactate, acetylCoA, CoA).

  2. Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury. [ Time Frame: End of surgical procedures ]
    The following biomarkers will be assessed: neuron specific enolase and S100B (for brain monitoring); high sensitive cardiac troponin T (for heart monitoring); Neutrophil Gelatinase-Associated Lipocalin (NGAL, for kidney monitoring); circulating endothelial cells counting and cytofluorimetric analysis (for endothelial monitoring).Systemic effects of intraoperative hypotension will be determine by measuring inflammatory cytokines (IL-6, IL-1 beta and TNF-alfa), oxidative stress biomarkers (reduced glutathione, lipid hydroperoxides) and markers of hypoxia (HIF1alpha, lactate, acetylCoA, CoA).


Secondary Outcome Measures :
  1. Incidence of hypotension during surgery [ Time Frame: End of surgical procedures ]
  2. Time spent in hypotension during surgery [ Time Frame: End of surgical procedures ]
  3. Patient-reported outcomes [ Time Frame: 30 days postsurgical procedure ]
    A telephone interview will be performed in order to investigate general health conditions and any re-admission to hospital.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or older;
  • Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours;
  • Planned to receive general anesthesia;
  • Planned to receive an arterial line during surgery;
  • Aim for MAP of 65 mmHg during surgery;
  • Being able to give written informed consent prior to surgery.

Exclusion Criteria:

Age less than 18 years;

  • Aim for MAP other than 65 mmHg at discretion treating physician;
  • Significant hypotension before surgery defined as a MAP <65;
  • Right- or left sided cardiac failure [e.g. left ventricular ejection fraction (LVEF)<35%];
  • Known cardiac shunts (significant);
  • Known aortic stenosis (severe);
  • Severe cardiac arrhythmias including atrial fibrillation;
  • Chronic kidney disease (as chronic kidney disease may affect the interpretation and prognostic significance of changes in urinary biomarkers);
  • Liver surgery;
  • Vascular surgery with clamping of the aorta;
  • Diabetes.

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): NCT03527758


Contacts
Contact: Paolo Murabito, MD 393293412022 paolomurabito@tiscali.it

Sponsors and Collaborators
University of Catania
Giovanni Li Volti
Marinella Astuto
Francesco Vasile
Gaetano Joseph Palumbo
Mirko Mineri
Christian Bonsignore
Salvatore Pennisi
Carmelo Minardi
Bruno Lanzafame
Luigi Lavia
Veronica Dezio

Responsible Party: Paolo Murabito, Assistant Professor, University of Catania
ClinicalTrials.gov Identifier: NCT03527758     History of Changes
Other Study ID Numbers: 46/2018/PO
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paolo Murabito, University of Catania:
Biomarkers
Hypotension
Organ Protection
Intraoperative

Additional relevant MeSH terms:
Craniocerebral Trauma
Brain Injuries
Renal Insufficiency
Hypotension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases