Permissive Hypotension After Cardiac Surgery

Completed · Not applicable

Conditions studied: Surgery

In brief

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.

Key facts

Study ID

NCT06476613

Run by

Massachusetts General Hospital

People needed

80

Starts

2024-04-20

Expected to finish

2026-07-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.