Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT03527758
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2018-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management
Sponsor:
University of Catania
Organization:
Study Overview
Official Title:
Correlation Between Circulating Biomarkers of Organs Damage and Intraoperative Hypotension Management
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Detailed Description:
The primary objective of this pilot study is to investigate if an early treatment of intraoperative hypotension driven by an Edwards Lifesciences new technology (Hypotension Probability Index - HPI software) and integrated hemodynamic variables is able to determine a modification of the blood levels of several specific biomarkers of tissue and organ damage compared to a traditional management of hypotension. It will also be evaluated if the management strategy of patient hemodynamics based on the Hypotension Probability Index (HPI) is associated with a lower incidence of hypotensive events and / or a shorter overall duration of intraoperative hypotension.
In the study will be enrolled forty adult patients requiring an arterial line (at discretion of treating physician) undergoing non-cardiac non-day surgery (with an expected duration of more than 2 hours and an aimed medium arterial pressure - MAP of 65 mmHg) at the Universitary Hospital of Catania.
The patients will be randomly (1:1) assigned to one of the subsequent two groups: a group monitored with FloTracIQ with HPI software (Treatment Group) and a group with standard invasive blood pressure monitoring (Control Group).
In the Control Group, all hypotensive episodes during surgery will be treated according to standard of care.
Patients randomized to the Treatment Group will receive monitoring with integration of HPI index and hemodynamic parameters visible on the EV1000 platform; these informations will be used to guide the investigator in the choice of the more appropriate treatment to be carried out. The value of HPI is updated every 20 seconds and expresses in percentage the probability of occurrence of a hypotensive event. The cut-off value of HPI is equal to 85%. Values above the cut-off are related to a higher probability of hypotension. A specific visual and sound "ALERT" will indicate to the investigator if the threshold value is reached / exceeded. Any treatment strategy will be based on integrated analysis of clinical and instrumental data showed on the screen of the EV1000 platform \[MAP, cardiac output (CO), systemic vascular resistance (SVR), stroke volume (SV), stroke volume variation (SVV), intra-ventricular pressure rate of rise (dP/dt), dynamic arterial elastance (Eadyn)\].
In both groups different blood samplings will be performed in order to assess biomarkers of specific organ dysfunction: T0 (baseline, before starting operating procedures); T1 (2 hours after starting anesthesia); T2 (at the 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). There will also be determined the systemic effect of intraoperative hypotension as measured by inflammatory cytokines \[Interleukin (IL)-6, IL-1 beta and Tumor necrosis factor (TNF)-alfa\], oxidative stress (reduced glutathione, lipid hydroperoxides) and markers of hypoxia (HIF1alpha, lactate, acetylCoA, CoA).
Various clinical informations will be collected at the same time: glomerular filtration rate, plasma electrolytes, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood gasses analysis, anion gap.
A telephone interview will be performed one month after surgery, in order to investigate general health condition and any re-admission to hospital.
Sample size calculation:
Given the pilot nature of the study, no formal justification of sample size has been made.
Statistical analysis:
For a test of normal distribution, the Kolmogorov-Smirnov test will be used. Continuous data with normal distribution will be tested with paired or unpaired t tests, non-normally distributed data using Mann-Whitney U test and Wilcoxon rank-sum test for unpaired and paired results, respectively.
Changes in biomarkers over time will be tested using analysis of variance (ANOVA) on repeated measurements. Categorical data will be tested using Chi-square test and Chi-square test for trend. Data will be presented as mean ± standard deviation when normally distributed and as median \[interquartile ranges\] in case of abnormal distribution. A p \< 0.05 will be considered statistically significant for all tests.
In the study will be enrolled forty adult patients requiring an arterial line (at discretion of treating physician) undergoing non-cardiac non-day surgery (with an expected duration of more than 2 hours and an aimed medium arterial pressure - MAP of 65 mmHg) at the Universitary Hospital of Catania.
The patients will be randomly (1:1) assigned to one of the subsequent two groups: a group monitored with FloTracIQ with HPI software (Treatment Group) and a group with standard invasive blood pressure monitoring (Control Group).
In the Control Group, all hypotensive episodes during surgery will be treated according to standard of care.
Patients randomized to the Treatment Group will receive monitoring with integration of HPI index and hemodynamic parameters visible on the EV1000 platform; these informations will be used to guide the investigator in the choice of the more appropriate treatment to be carried out. The value of HPI is updated every 20 seconds and expresses in percentage the probability of occurrence of a hypotensive event. The cut-off value of HPI is equal to 85%. Values above the cut-off are related to a higher probability of hypotension. A specific visual and sound "ALERT" will indicate to the investigator if the threshold value is reached / exceeded. Any treatment strategy will be based on integrated analysis of clinical and instrumental data showed on the screen of the EV1000 platform \[MAP, cardiac output (CO), systemic vascular resistance (SVR), stroke volume (SV), stroke volume variation (SVV), intra-ventricular pressure rate of rise (dP/dt), dynamic arterial elastance (Eadyn)\].
In both groups different blood samplings will be performed in order to assess biomarkers of specific organ dysfunction: T0 (baseline, before starting operating procedures); T1 (2 hours after starting anesthesia); T2 (at the 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). There will also be determined the systemic effect of intraoperative hypotension as measured by inflammatory cytokines \[Interleukin (IL)-6, IL-1 beta and Tumor necrosis factor (TNF)-alfa\], oxidative stress (reduced glutathione, lipid hydroperoxides) and markers of hypoxia (HIF1alpha, lactate, acetylCoA, CoA).
Various clinical informations will be collected at the same time: glomerular filtration rate, plasma electrolytes, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood gasses analysis, anion gap.
A telephone interview will be performed one month after surgery, in order to investigate general health condition and any re-admission to hospital.
Sample size calculation:
Given the pilot nature of the study, no formal justification of sample size has been made.
Statistical analysis:
For a test of normal distribution, the Kolmogorov-Smirnov test will be used. Continuous data with normal distribution will be tested with paired or unpaired t tests, non-normally distributed data using Mann-Whitney U test and Wilcoxon rank-sum test for unpaired and paired results, respectively.
Changes in biomarkers over time will be tested using analysis of variance (ANOVA) on repeated measurements. Categorical data will be tested using Chi-square test and Chi-square test for trend. Data will be presented as mean ± standard deviation when normally distributed and as median \[interquartile ranges\] in case of abnormal distribution. A p \< 0.05 will be considered statistically significant for all tests.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: