RECRUITING

Permissive Hypotension After Cardiac Surgery

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pilot Study- Permissive Hypotension After Cardiac Surgery

Quick Facts

Study Start:2024-04-20
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06476613

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Schedules for elective or non-emergent cardiac surgery
  1. * 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
  2. * Rapidly increasing pressors within 60 mins of arrival.
  3. * Significant prior renal dysfunction (CKD \>4), hemodialysis dependence
  4. * Cirrhosis
  5. * A neuropathology diagnosis warranting blood pressure goal
  6. * Pre-specified MAP goal as determined by clinical team
  7. * Carotid stenosis (\> 50%) or prior stroke
  8. * Bleeding requiring return to the OR
  9. * Need for mechanical circulatory support
  10. * Heart and Lung transplantation
  11. * Aortic dissection

Contacts and Locations

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-20
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2024-04-20
Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Surgery