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Completed

NCT Number: NCT06476613

Permissive Hypotension After Cardiac Surgery

The objective of this pilot randomized controlled trial is to demonstrate the feasibility of implementing a pragmatic clinical trial randomizing patients to permissive hypotension versus usual care and to determine the impact of permissive hypotension on vasopressor exposure, ICU length of stay, markers of end organ perfusion, and clinically relevant patient outcomes. The data collected from this pilot study will be used as preliminary data for study design and grant applications for a larger multicenter randomized controlled trial.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

The investigators will perform a single center, open-label, randomized controlled trial in patients admitted to the HCICU after cardiac surgery at MGH. Patients who are hypotensive (MAP < 65mmHg) and/or require vasopressor support to maintain a MAP ≥ 65mmHg during the first 24 hours of ICU admission will be eligible for randomization. Patients will be randomized in 1:1 fashion to either a) Permissive Hypotension (MAP target >60mmHg) or b) Usual Care. The duration of the intervention will extend until the patient no longer needs vasopressors to maintain prespecified MAP. Outcomes of interest include continuous hemodynamics (both recorded values from EHR as well as the arterial line waveform data), vasopressor exposure (as measured by maximum Vasopressor-Inotrope Score, mean Vasopressor-Inotrope Score, and duration of vasopressor use), lactate clearance, rates of atrial fibrillation, need for renal replacement therapy, ICU length of stay, survival to hospital discharge, cognitive state at discharge using Montreal Cognitive Assessment score. Additionally, the investigators will perform exploratory analyses using the continuous arterial line waveform data to evaluate for potential differences in arterial waveform morphologies between groups to help discern the hemodynamic impacts of permissive hypotension and to potentially identify subphenotypes who may derive greater benefit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Schedules for elective or non-emergent cardiac surgery

Exclusion criteria

  • Arrival to the CICU with severe shock determined any of the following: Norepinephrine dose >20mcg/min, Epinephrine >3mcg/min, Dobutamine >2.5mcg/kg/min, Milrinone >0.2mcg/kg/min
  • Rapidly increasing pressors within 60 mins of arrival.
  • Significant prior renal dysfunction (CKD >4), hemodialysis dependence
  • Cirrhosis
  • A neuropathology diagnosis warranting blood pressure goal
  • Pre-specified MAP goal as determined by clinical team
  • Carotid stenosis (> 50%) or prior stroke
  • Bleeding requiring return to the OR
  • Need for mechanical circulatory support
  • Heart and Lung transplantation
  • Aortic dissection

Treatment and study plan

Permissive Hypotension

Other

Patients will be randomized in 1:1 fashion to either a) Permissive Hypotension (MAP target > 60mmHg) or b) Usual Care. The duration of the intervention will extend until the patient no longer needs vasopressors to maintain prespecified MAP.

Primary outcomes

  1. MAP in mmHg

    Time frame: Through study completion, an average of 2 to 3 days

    (Mean arterial pressure) measured in millimetres of mercury

  2. Vasoactive-Inotropic Score for duration of pressor need

    Time frame: Through study completion, an average of 2 to 3 days

    Weighted sum of all administered vasopressor and inotropic medications and quantifies the amount of pharmacological support in patients

Secondary outcomes

  1. ICU and hospital length of stay

    Time frame: Through study completion, an average of a week

    Total ICU and hospital length of stay following cardiac surgery

  2. Duration of inotrope and vasopressor exposure

    Time frame: Through study completion, an average of 2 to 3 days

    Total duration of inotrope and vasopressor support required

  3. Duration of end organ support

    Time frame: Through study completion, an average of 2 to 3 days

    Total duration for end organ support

  4. Mortality

    Time frame: Through study completion, an average of a week

    Occurrence of death during study intervention

  5. Cognitive function assessed using Montreal Cognitive Assessment (MOCA)

    Time frame: Through study completion, an average of a week

    Brief screening instrument for cognitive function

  6. Tissue perfusion pressure via continuous arterial waveform monitoring

    Time frame: Through study completion, an average of 2 to 3 days

    Hemodynamic monitoring to ensure optimal tissue perfusion and oxygen delivery

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Pilot Study- Permissive Hypotension After Cardiac Surgery

Acronym: PHACS

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 26, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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