Permissive Hypotension After Cardiac Surgery (PHACS)

November 27, 2025 updated by: Asishana A Osho, Massachusetts General Hospital

Pilot Study- 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Permissive hypotension Intervention
In addition to the regular care provided to cardiac surgery patients, those in the permissive hypotension intervention arm will have a MAP target > 60mmHg.
Other: Permissive Hypotension
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.
No Intervention: Standard of Care
Patients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAP in mmHg
Time Frame: Through study completion, an average of 2 to 3 days
(Mean arterial pressure) measured in millimetres of mercury
Through study completion, an average of 2 to 3 days
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
Through study completion, an average of 2 to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of a week
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
Through study completion, an average of 2 to 3 days
Duration of end organ support
Time Frame: Through study completion, an average of 2 to 3 days
Total duration for end organ support
Through study completion, an average of 2 to 3 days
Mortality
Time Frame: Through study completion, an average of a week
Occurrence of death during study intervention
Through study completion, an average of a week
Cognitive function assessed using Montreal Cognitive Assessment (MOCA)
Time Frame: Through study completion, an average of a week
Brief screening instrument for cognitive function
Through study completion, an average of a week
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
Through study completion, an average of 2 to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 23, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P003142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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