Permissive Hypotension After Cardiac Surgery

Description

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.

Conditions

Surgery

Study Overview

Study Details

Study overview

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.

Pilot Study- Permissive Hypotension After Cardiac Surgery

Permissive Hypotension After Cardiac Surgery

Condition
Surgery
Intervention / Treatment

-

Contacts and Locations

Boston

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Study Record Dates

2026-03-01