Using permissive hypotension after cardiac surgery
Pilot Study- Permissive Hypotension After Cardiac Surgery
NA · Massachusetts General Hospital · NCT06476613
This study is testing if allowing lower blood pressure after heart surgery helps patients in the ICU recover better compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06476613 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the feasibility of implementing permissive hypotension in patients after cardiac surgery. Patients admitted to the ICU who are hypotensive or require vasopressor support will be randomized to receive either permissive hypotension or usual care. The study will assess various outcomes, including vasopressor exposure, ICU length of stay, and markers of organ perfusion. Data collected will inform the design of a larger multicenter trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective or non-emergent cardiac surgery and experience hypotension post-surgery.
Not a fit: Patients arriving with severe shock or significant prior renal dysfunction, among other exclusion criteria, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient outcomes and reduced reliance on vasopressors after cardiac surgery.
How similar studies have performed: While this approach is being explored in this pilot study, similar studies on permissive hypotension have shown promise, but this specific application in cardiac surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Surgery