Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476613
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-07
Brief Title:
Permissive Hypotension After Cardiac Surgery
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Study- Permissive Hypotension After Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHACS
Brief Summary:
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
Detailed Description:
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 andor 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None