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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 - The HYPE-2 Randomized Clinical Trial

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 - The HYPE-2 Randomized Clinical Trial - HYPE-2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51117
Enrollment
130
Registered
2021-04-26
Start date
2021-05-19
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamiek, intraoperatief en tijdens intensive care opname Hypotension low blood pressure

Interventions

The intervention used in the treatment arm will consist of: HemoSphere with Acumen IQ variables including HPI and diagnostic guidance. HPI will be calculated via Acumen IQ sensor connected to the ra

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 (excluding pump time) and mechanically ventilated duration of ICU admission

Exclusion criteria

Exclusion criteria: • Known cardiac shunts (significant) • Severe cardiac arrhythmias (including but not limited to persistent atrial fibrillation prior to surgery) • Expected to receive a 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

Design outcomes

Primary

MeasureTime frame
The overall TWA of hypotension 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

MeasureTime frame
All secondary objectives 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): • Incidence of hypotension • Time spent in hypotension • The percentage of time in hypotension • The area under the curve (AUC) of a MAP

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)