Permissive Hypotension After Cardiac Surgery (PHACS)

Mass General Brigham

Status: Enrolling

Conditions: Surgery

Treatments: Other: Permissive Hypotension

Study type: Interventional

Funder types: Other

Identifiers

NCT06476613

2023P003142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Permissive hypotension Intervention

Experimental group

Description:

In addition to the regular care provided to cardiac surgery patients, those in the permissive hypotension intervention arm will have a MAP target \> 60mmHg.

Treatment:

Other: Permissive Hypotension

Standard of Care

No Intervention group

Description:

Patients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients.