Surgery
Conditions
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) and/or 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 1:1 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.
Interventions
OTHERPermissive Hypotension
Patients will be randomized in 1:1 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAP in mmHg | Through study completion, an average of 2 to 3 days | (Mean arterial pressure) measured in millimetres of mercury |
| Vasoactive-Inotropic Score for duration of pressor need | Through study completion, an average of 2 to 3 days | Weighted sum of all administered vasopressor and inotropic medications and quantifies the amount of pharmacological support in patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU and hospital length of stay | Through study completion, an average of a week | Total ICU and hospital length of stay following cardiac surgery |
| Duration of inotrope and vasopressor exposure | Through study completion, an average of 2 to 3 days | Total duration of inotrope and vasopressor support required |
| Duration of end organ support | Through study completion, an average of 2 to 3 days | Total duration for end organ support |
| Mortality | Through study completion, an average of a week | Occurrence of death during study intervention |
| Cognitive function assessed using Montreal Cognitive Assessment (MOCA) | Through study completion, an average of a week | Brief screening instrument for cognitive function |
| Tissue perfusion pressure via continuous arterial waveform monitoring | Through study completion, an average of 2 to 3 days | Hemodynamic monitoring to ensure optimal tissue perfusion and oxygen delivery |
Countries
United States
Outcome results
None listed