Clinical trial NCT06476613: Permissive Hypotension After Cardiac Surgery
Official title: Pilot Study- Permissive Hypotension After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: MAP in mmHg
timeFrame: Through study completion, an average of 2 to 3 days
measure: Vasoactive-Inotropic Score for duration of pressor need
timeFrame: Through study completion, an average of 2 to 3 days
Secondary outcomes:
measure: ICU and hospital length of stay
timeFrame: Through study completion, an average of a week
measure: Duration of inotrope and vasopressor exposure
timeFrame: Through study completion, an average of 2 to 3 days
measure: Duration of end organ support
timeFrame: Through study completion, an average of 2 to 3 days
measure: Mortality
timeFrame: Through study completion, an average of a week
measure: Cognitive function assessed using Montreal Cognitive Assessment (MOCA)
timeFrame: Through study completion, an average of a week
measure: Tissue perfusion pressure via continuous arterial waveform monitoring
timeFrame: Through study completion, an average of 2 to 3 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Koponen T, Karttunen J, Musialowicz T, Pietilainen L, Uusaro A, Lahtinen P. Vasoactive-inotropic score and the prediction of morbidity and mortality after cardiac surgery. Br J Anaesth. 2019 Apr;122(4):428-436. doi: 10.1016/j.bja.2018.12.019. Epub 2019 Feb 18.
citation: Lamontagne F, Richards-Belle A, Thomas K, Harrison DA, Sadique MZ, Grieve RD, Camsooksai J, Darnell R, Gordon AC, Henry D, Hudson N, Mason AJ, Saull M, Whitman C, Young JD, Rowan KM, Mouncey PR; 65 trial investigators. Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial. JAMA. 2020 Mar 10;323(10):938-949. doi: 10.1001/jama.2020.0930.
citation: Lamontagne F, Marshall JC, Adhikari NKJ. Permissive hypotension during shock resuscitation: equipoise in all patients? Intensive Care Med. 2018 Jan;44(1):87-90. doi: 10.1007/s00134-017-4849-2. Epub 2017 May 27. No abstract available.
citation: Lamontagne F, Meade MO, Hebert PC, Asfar P, Lauzier F, Seely AJE, Day AG, Mehta S, Muscedere J, Bagshaw SM, Ferguson ND, Cook DJ, Kanji S, Turgeon AF, Herridge MS, Subramanian S, Lacroix J, Adhikari NKJ, Scales DC, Fox-Robichaud A, Skrobik Y, Whitlock RP, Green RS, Koo KKY, Tanguay T, Magder S, Heyland DK; Canadian Critical Care Trials Group.. Higher versus lower blood pressure targets for vasopressor therapy in shock: a multicentre pilot randomized controlled trial. Intensive Care Med. 2016 Apr;42(4):542-550. doi: 10.1007/s00134-016-4237-3. Epub 2016 Feb 18.