Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347211
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-29
Brief Title:
Hypotension Probability Indicator in TAVIMitraClip for Hypotension Management
Sponsor:
Attikon Hospital
Organization:
Attikon Hospital
Study Overview
Official Title:
Is The Hypotension Probability Indicator With Goal Directed Haemodynamic Treatment Useful In Predicting And Treating Hypotension In Patients Undergoing Transcatheter Aortic Valve ImplantationTAVI or MitraClip
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension
Detailed Description:
The perioperative period is characterized by hemodynamic instability Intraoperative hypotension IOH can be caused by anesthesia drugs surgical manipulations hypovolemia or inhibition of the sympathetic nervous system and impairment of baroreflex regulatory mechanisms In a retrospective analysis performed at the Cleveland Clinic the risk for acute kidney injuryAKI and myocardial injury MI increased when mean arterial pressure MAP was less than 55 mmHg Further even short durations of intraoperative hypotension were associated with AKI and MI Salmasi and coll analyzed whether associations based on relative thresholds were stronger than those based on absolute thresholds regarding blood pressure They found that there were no clinically important interactions between preoperative blood pressures and the relationship between hypotension and MI or AKI at intraoperative mean arterial blood pressures less than 65 mmHg Absolute and relative thresholds had comparable ability to discriminate patients with MI or AKI from those without it The authors concluded that anesthetic management can thus be based on intraoperative pressures without regard to preoperative pressure In a retrospective cohort study Sun and coll conclude that an increased risk of postoperative stage I AKI occurs when intraoperative MAP was less than 60 mmHg for more than 20 min and less than 55 mmHg for more than 10 min
Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse followed by prompt treatment and ultimately reversal of the responsible process Recently a Hypotension Probability Indicator HPI algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases The HPI algorithm can be integrated with a goal-directed hemodynamic treatment GDHT to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure The HPI index combined with a hypotension management protocol has shown efficacy in reducing hypotension during surgical procedures Its effectiveness has been demonstrated in ICU patients with Covid-19 Studies in cardiac surgery cases have been conducted with ongoing research in cardiac surgery patients HYPE2 and HPI Care Trial Maintaining stable arterial pressure and avoiding intraoperative hypotension are crucial during TAVI or MitraClip procedures achieved through monitored anesthesia care MAC or general anesthesia Based on recent publications and Pinskys work a hypotension management protocol integrating GDHT with the HPI algorithm has been developed for TAVI or MitraClip patients
Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse followed by prompt treatment and ultimately reversal of the responsible process Recently a Hypotension Probability Indicator HPI algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases The HPI algorithm can be integrated with a goal-directed hemodynamic treatment GDHT to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure The HPI index combined with a hypotension management protocol has shown efficacy in reducing hypotension during surgical procedures Its effectiveness has been demonstrated in ICU patients with Covid-19 Studies in cardiac surgery cases have been conducted with ongoing research in cardiac surgery patients HYPE2 and HPI Care Trial Maintaining stable arterial pressure and avoiding intraoperative hypotension are crucial during TAVI or MitraClip procedures achieved through monitored anesthesia care MAC or general anesthesia Based on recent publications and Pinskys work a hypotension management protocol integrating GDHT with the HPI algorithm has been developed for TAVI or MitraClip patients
Study Oversight
Has Oversight DMC:
None
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?:
None