Clinical trial NCT04803903: HPI Index With GDHT in Predicting Hypotension In General Anesthesia Patients
Official title: Is The Hypotension Probability Indicator With Goal Directed Haemodynamic Treatment Useful In Predicting And Treating Hypotension In General Anesthesia Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension During Surgery
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We selected adults (age 18 years or older), that underwent surgery lasting for more that 2 hours in which an arterial line was deemed necessary for their hemodynamic monitoring and treatment

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 injury (AKI) 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 ΜΙ or ΑΚΙ at intraoperative mean arterial blood pressures less than 65 mmHg. Absolute and relative thresholds had comparable ability to discriminate patients with ΜΙ or ΑΚΙ 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. We developed a treatment protocol implementing HPI with GDHT that can be used in general anesthesia patients to guide clinical practice.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Planned to receive general anaesthesia \> 2h
* 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:

* 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. LVEF\<35%)
* Known cardiac shunts (significant)
* Known aortic stenosis (severe)
* Severe cardiac arrhythmias including atrial fibrillation
* Requiring dialysis
* Liver surgery with Pringle maneuver
* Vascular surgery with clamping of the aorta

Primary outcomes:
measure: TWA hypotension (measured with Flotrac sensor)
timeFrame: intraoperative, starting 15 minutes after induction
Secondary outcomes:
measure: Incidence of hypotension (measured with Flotrac sensor)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Time spent in hypotension (measured with Flotrac sensor)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Treatment choice (drugs/fluids)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Treatment dose (drugs/fluids)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Time to treatment (drugs/fluids)
timeFrame: intraoperative, starting 15 minutes after induction
measure: Diagnostic guidance protocol deviations
timeFrame: intraoperative, starting 15 minutes after induction
measure: Postoperative Morbidity
timeFrame: postoperative, up to 30 days after surgery or until discharge from the hospital
measure: Postoperative Creatinine levels
timeFrame: postoperative, up to 30 days after surgery or until discharge from the hospital
measure: Mortality
timeFrame: postoperative, up to 30 days after surgery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon University Hospital
state: Attika
Study officials:
affiliation: Attikon Hospital
name: Tatiana Sidiropoulou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
citation: Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
citation: Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.