Permissive Hypotension After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2026-10-01

Brief Summary

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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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Detailed Description

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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

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Permissive Hypotension

Intervention Type 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.

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No