Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management

NCT03527758 | Completed

• 1 other identifier: 46/2018/PO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypotension; Brain Injuries; Renal Failure; Endothelial Dysfunction

Keywords

Biomarkers; Hypotension; Organ Protection; Intraoperative

Outcome Measures

Primary Outcomes (2)

• Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury.

  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 hours after starting anesthesia

• Variation from basal of the levels of biomarkers of brain, heart, kidney and endothelial injury.

  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).

  End of surgical procedures

Secondary Outcomes (3)

• Incidence of hypotension during surgery

  End of surgical procedures

• Time spent in hypotension during surgery

  End of surgical procedures

• Patient-reported outcomes

  30 days postsurgical procedure

Study Arms (2)

Standard Invasive intraoperative monitoring

NO INTERVENTION

Flo TracIQ with HPI software

EXPERIMENTAL

Device: Flo TracIQ with HPI software

Interventions

Flo TracIQ with HPI software DEVICE

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.

Flo TracIQ with HPI software

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catania: lead
• Giovanni Li Volti: collaborator
• Marinella Astuto: collaborator
• Francesco Vasile: collaborator
• Gaetano Joseph Palumbo: collaborator
• Mirko Mineri: collaborator
• Christian Bonsignore: collaborator
• Salvatore Pennisi: collaborator
• Carmelo Minardi: collaborator
• Bruno Lanzafame: collaborator
• Luigi Lavia: collaborator
• Veronica Dezio: collaborator

Study Sites (1)

"G. Rodolico" Presidium of the Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele"

Catania, 95123, Italy

Location

MeSH Terms

Conditions

Hypotension; Brain Injuries; Renal Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 17, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: January 15, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

IT (1)