NL-OMON51117CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 142
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
Investigators
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