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The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anesthesia (PRETREAT): an adaptive, multicenter randomized controlled trial

The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anesthesia (PRETREAT): an adaptive, multicenter randomized controlled trial - PRETREAT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55117
Enrollment
5000
Registered
2021-03-05
Start date
2021-06-17
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Postoperatief functioneren en kwaliteit van leven Hypotension

Interventions

The hypothesis of this study is that a proactive strategy keeps the blood pressure at a safe margin and avoids dropping below the minimal acceptable threshold of a MAP of 65 mmHg. The proactive stra
2) a guideline with suggestions how to keep patients at their target blood pressure. Patients with a high likelihood of IOH require larger safety margins and thus higher target blood pressures compa

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients scheduled for elective non-cardiac surgery under general anesthesia or central neuraxial anesthesia with a scheduled stay at the hospital after surgery of at least one night - i.e. inpatients - will be considered eligible for inclusion

Exclusion criteria

Exclusion criteria: Patients will be excluded when scheduled for low risk surgery, such as ophthalmic surgery, endoscopic gastrointestinal procedures, and (interventional) radiologic procedures. Also all other procedures under 30 minutes and obstetric or organ transplantations will be excluded.

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is persistent functional disability at six months after surgery, measured with the 12-item WHODAS 2.0 questionnaire

Secondary

MeasureTime frame
Secondary outcomes for the trial are: functional disability after 30 days (WHODAS 2.0), quality of live after 30 days and six months (EQ-5D-5L questionnaire), six-months mortality, in-hospital mortality, length of hospital stay, and in-hospital complications, i.e. acute kidney injury, myocardial injury, stroke, unexpected admission at the intensive care unit, and postoperative use of non-prophylactic antibiotics.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 2, 2026