Clinical trial NCT05821647: Hypotension Prediction 2 Study in Cardiac Surgery and Postoperative ICU Admission
Official title: Effect of a Machine Learning-Derived Early Warning System for Hypotension vs Standard Care on Depth and Duration of Intra- and Postoperative Hypotension in Elective Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Postoperative Hypotension
Hypotension
Keywords: Intensive Care Unit
Cardiac surgery
Coronary Artery Bypass Grafting
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2023-04-20
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms in which patients are allocated in a 1:1 randomization ratio.
Primary purpose: PREVENTION

Brief summary: This trial registration serves as an amendment incorporating the IPD Sharing Statement.

This study already has a trial registration (2021 April 30) in the Netherlands Trial Registry (Reference number NL9449, https://trialsearch.who.int/). However, the NTR register is subject to a merger with another Dutch register. This means that existing registrations are still visible, but can no longer be adjusted.

Study summary:

Hypotension in the operating room (OR) and during post-operative ICU admission is common in surgical patients and even more prevalent in cardiac surgery patients. It is associated with adverse outcomes and while these events are preventable, current management is predominantly reactive. Edwards Lifesciences (Irvine, CA) has developed the Hypotension Prediction Index (HPI), an early warning system that predicts an hypotensive event, defined as MAP below 65 mmHg, with high accuracy minutes before it occurs. At the time of writing the protocol this model has not been tested in a clinical trial in cardiac surgery patients or ICU admitted patients. The aim of the HYPE-2 trial is to assess whether the HPI-algorithm can reduce the time-weighted average (TWA) of intra- and postoperative hypotension in elective on-pump coronary artery bypass graft (CABG) surgery patients.

Detailed description: Population studied:

All adult patients undergoing elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement), requiring a radial arterial line and an intended target MAP of 65 mmHg or above during both surgery (excluding cardiopulmonary bypass pump time (CBP)) and during mechanically ventilated phase of duration of ICU admission.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older at inclusion
* Planned for elective on-pump CABG surgery or CABG with additional single heart valve surgery (e.g. valve repair or replacement)
* Planned to receive standard monitoring for cardiac surgery
* Target MAP of 65 mmHg or above during surgery
* Target MAP of 65 mmHg or above during the mechanically ventilated phase of ICU admission

Exclusion Criteria:

* Known cardiac shunts (significant)
* Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery)
* Expected to receive an hemodynamic assist device (e.g. intra-aortic balloon pump) during surgery
* Dialysis dependent kidney failure prior to surgery
* Planned to receive Perioperative Goal Directed Therapy (PGDT) other than standard intraoperative care
* Previous cardiac surgery in medical history

Primary outcomes:
measure: The overall time-weighted average (TWA) of hypotension (severity of hypotension)
timeFrame: During both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Secondary outcomes:
measure: Incidence of hypotension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Time spent in hypotension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: The percentage of time in hypotension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: The AUT of a MAP < 65 mmHg
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Incidence of hypertension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Time spent in hypertension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: The percentage of time in hypertension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: The AAT of a MAP > 100 mmHg
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: TWA of hypertension
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Incidence of HPI alarm (HPI ≥ 75)
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Time spent in HPI alarm
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: The percentage of time in HPI alarm
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: The AAT of a HPI ≥ 75
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: TWA of HPI alarm
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Treatment choice
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Treatment dose
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Time to treatment
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Number of treatments
timeFrame: Will be analyzed for the overall duration of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
Other outcomes:
measure: Incidence of hypertension (intraoperative)
timeFrame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: Incidence of hypertension (postoperative in the ICU)
timeFrame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Time spent in hypertension (intraoperative)
timeFrame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: Time spent in hypertension (postoperative in the ICU)
timeFrame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: TWA of hypertension (intraoperative)
timeFrame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: TWA of hypertension (postoperative in the ICU)
timeFrame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Incidence of HPI alarm (HPI ≥ 75) (intraoperative)
timeFrame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: Incidence of HPI alarm (HPI ≥ 75) (postoperative in the ICU)
timeFrame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Time spent in HPI alarm (intraoperative)
timeFrame: During both the off-pump phases of on-pump CABG surgery (up to 8 hours)
measure: Time spent in HPI alarm (postoperative in the ICU)
timeFrame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: TWA of HPI alarm (intraoperative)
timeFrame: During both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: TWA of HPI alarm (postoperative in the ICU)
timeFrame: During the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Compliance of clinicians to HPI treatment protocol + diagnostic guidance
timeFrame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Association between decrease in TWA of hypotension and a difference in creatinine (μmol/L)
timeFrame: Admission at ICU admission, and every morning of hospitalization after surgery (up to 28 days)
measure: Association between decrease in TWA of hypotension and a difference in lactate (mmol/L)
timeFrame: All lactate samples taken during the study phases and the samples taken every morning during ICU admission (up to 28 days)
measure: Association between decrease in TWA of hypotension and a difference in creatinine kinase MB (μg/L)
timeFrame: During ICU admission (up to 28 days)
measure: Association between decrease in TWA of hypotension and a difference in hematocrit (L/L)
timeFrame: During ICU admission (up to 28 days)
measure: Association between decrease in TWA of hypotension and a difference in central venous oxygen saturation (%)
timeFrame: All samples taken during the study phases until the first sample after extubation at ICU (up to 28 days)
measure: Association between decrease in TWA of hypotension and a difference in brain natriuretic peptide (ng/L)
timeFrame: During ICU admission (up to 28 days)
measure: Sustained effect on TWA of hypotension
timeFrame: After HPI and diagnostic guidance is disconnected up to 8 hours after discontinuation.
measure: Sustained effect on incidence of hypotension
timeFrame: After HPI and diagnostic guidance is disconnected up to 8 hours after discontinuation.
measure: Sustained effect on time spent in hypotension
timeFrame: After HPI and diagnostic guidance is disconnected up to 8 hours after discontinuation.
measure: Difference in treatment behaviour between groups expressed as total number of alarms (n)
timeFrame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Difference in treatment behaviour between groups expressed as number of alarms per patients (n)
timeFrame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Difference in treatment behaviour between groups expressed as total percentage of alarms treated (%)
timeFrame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Difference in treatment behaviour between groups expressed as time from alarm to first treatment action (seconds).
timeFrame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Difference in treatment behaviour between groups expressed as time from first alarm to first treatment action (seconds).
timeFrame: Will be analyzed for all study phases of both the off-pump phases of on-pump CABG surgery and the mechanically ventilated phase of post-operative ICU admission (or 8 hours maximum)
measure: Assess required treatment during hypotension (MAP < 65 mmHg) within both off-pump phases of on-pump CABG surgery as the determined by the anesthesiologist based on transesophageal echocardiogram (TEE) observations.
timeFrame: During hemodynamic instability (hypotension) within both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: Assess required treatment during hypotension (MAP < 65 mmHg) within both off-pump phases of on-pump CABG surgery as the determined by the diagnostic guidance protocol.
timeFrame: During hemodynamic instability (hypotension) within both the off-pump phases of on-pump CABG surgery (or 8 hours maximum)
measure: Relation between required treatment as determined by the anesthesiologist's expertise using TEE observations versus the required treatment as determined using the diagnostic guidance protocol.
timeFrame: During hemodynamic instability within both the off-pump phases of on-pump CABG surgery (up to 8 hours)
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Amsterdam University Medical Centers
state: Noord-Holland
Study officials:
affiliation: Department of Intensive Care, Amsterdam UMC, location AMC, Amsterdam, the Netherlands
name: A.P.J. Vlaar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
citation: Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.