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Permissive Hypotension for Surgery (PHACS Trial)

N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Schedules for elective or non-emergent cardiac surgery
Must not have
Arrival to the CICU with severe shock determined by any of the following: Norepinephrine dose >20mcg/min, Epinephrine >3mcg/min, Dobutamine >2.5mcg/kg/min, Milrinone >0.2mcg/kg/min
Cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 to 3 days
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test if it's possible to conduct a study where patients are randomly assigned to either receiving lower blood pressure treatment or standard care. The goal is to see how this lower blood pressure treatment

Who is the study for?
This trial is for patients who have low blood pressure following cardiac surgery. The study aims to include individuals who can safely participate in a comparison of permissive hypotension versus usual care post-surgery.
What is being tested?
The trial is testing the approach of allowing lower than normal blood pressure (permissive hypotension) after heart surgery, compared to the standard treatment. It will look at how this affects the need for drugs that raise blood pressure, ICU stay duration, organ function, and overall patient outcomes.
What are the potential side effects?
Since this trial involves managing low blood pressure without intervention, potential side effects may include symptoms related to reduced blood flow such as dizziness or fainting. However, specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for a planned heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was admitted to the ICU in severe shock needing high doses of specific heart medications.
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I have cirrhosis.
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I have had a heart or lung transplant.
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I have had a stroke or my carotid artery is more than half blocked.
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I had to return to surgery due to bleeding.
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I have an aortic dissection.
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I have severe kidney problems or need dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 to 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 to 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MAP in mmHg
Vasoactive-Inotropic Score for duration of pressor need
Secondary study objectives
Cognitive function assessed using Montreal Cognitive Assessment (MOCA)
Duration of end organ support
Duration of inotrope and vasopressor exposure
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Permissive hypotension InterventionExperimental Treatment1 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.
Group II: Standard of CareActive Control1 Intervention
Patients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,002 Previous Clinical Trials
13,309,520 Total Patients Enrolled
7 Trials studying Surgery
186,944 Patients Enrolled for Surgery
~53 spots leftby Mar 2026
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