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SurgeryPHACSNCT06476613

Permissive Hypotension After Cardiac Surgery

A study testing Permissive Hypotension in people with Surgery, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery
What is being tested?
Permissive Hypotension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
20 Apr 2024to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • Carotid stenosis (> 50%) or prior stroke
  • Bleeding requiring return to the OR
  • Need for mechanical circulatory support
  • Heart and Lung transplantation
  • Aortic dissection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Surgery
Being tested
Permissive Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Permissive HypotensionOther

    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.

Study groups in NCT06476613
Study groupRoleWhat they receive
Permissive hypotension InterventionExperimentalIn addition to the regular care provided to cardiac surgery patients, those in the permissive hypotension intervention arm will have a MAP target > 60mmHg.
Receives: Other: Permissive Hypotension
Standard of CareNo interventionPatients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MAP in mmHg

    (Mean arterial pressure) measured in millimetres of mercury

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

  2. Vasoactive-Inotropic Score for duration of pressor need

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

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

Secondary outcomes (6)

  1. ICU and hospital length of stay

    Total ICU and hospital length of stay following cardiac surgery

    Measured: Through study completion, an average of a week

  2. Duration of inotrope and vasopressor exposure

    Total duration of inotrope and vasopressor support required

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

  3. Duration of end organ support

    Total duration for end organ support

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

  4. Mortality

    Occurrence of death during study intervention

    Measured: Through study completion, an average of a week

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

    Brief screening instrument for cognitive function

    Measured: Through study completion, an average of a week

  6. Tissue perfusion pressure via continuous arterial waveform monitoring

    Hemodynamic monitoring to ensure optimal tissue perfusion and oxygen delivery

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2024
  2. Study start20 Apr 2024
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06476613
Sponsor's protocol ID
2023P003142
Acronym
PHACS
Status last verified
Jul 2025
First submitted
7 Jun 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Koponen T, Karttunen J, Musialowicz T, Pietilainen L, Uusaro A, Lahtinen P. Vasoactive-inotropic score and the prediction of morbidity and mortality after cardiac surgery. Br J Anaesth. 2019 Apr;122(4):428-436. doi: 10.1016/j.bja.2018.12.019. Epub 2019 Feb 18.

    PubMed 30857599

  • Lamontagne F, Richards-Belle A, Thomas K, Harrison DA, Sadique MZ, Grieve RD, Camsooksai J, Darnell R, Gordon AC, Henry D, Hudson N, Mason AJ, Saull M, Whitman C, Young JD, Rowan KM, Mouncey PR; 65 trial investigators. Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial. JAMA. 2020 Mar 10;323(10):938-949. doi: 10.1001/jama.2020.0930.

    PubMed 32049269

  • Lamontagne F, Marshall JC, Adhikari NKJ. Permissive hypotension during shock resuscitation: equipoise in all patients? Intensive Care Med. 2018 Jan;44(1):87-90. doi: 10.1007/s00134-017-4849-2. Epub 2017 May 27. No abstract available.

    PubMed 28551721

  • Lamontagne F, Meade MO, Hebert PC, Asfar P, Lauzier F, Seely AJE, Day AG, Mehta S, Muscedere J, Bagshaw SM, Ferguson ND, Cook DJ, Kanji S, Turgeon AF, Herridge MS, Subramanian S, Lacroix J, Adhikari NKJ, Scales DC, Fox-Robichaud A, Skrobik Y, Whitlock RP, Green RS, Koo KKY, Tanguay T, Magder S, Heyland DK; Canadian Critical Care Trials Group.. Higher versus lower blood pressure targets for vasopressor therapy in shock: a multicentre pilot randomized controlled trial. Intensive Care Med. 2016 Apr;42(4):542-550. doi: 10.1007/s00134-016-4237-3. Epub 2016 Feb 18.

    PubMed 26891677

  • Miranda DW, Makarem A, Liquori C, Galvis A, Bagchi A, Nikolic I, Aguirre AD, Bloom JP, Rabi SA, D'Alessandro DA, Melnitchouk S, Jassar AS, Langer NB, Hosseini M, Kreso A, Sundt TM, Osho AA, Silverman MG. Rationale and design of a pilot randomized control trial of permissive hypotension after cardiac surgery: The PHACS trial. Am Heart J Plus. 2026 Aug 2;70:100852. doi: 10.1016/j.ahjo.2026.100852. eCollection 2026 Oct.

    PubMed 42656614

Questions about this trial

What is this clinical trial studying?

A study testing Permissive Hypotension in people with Surgery, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MAP in mmHg (time frame: Through study completion, an average of 2 to 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06476613, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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