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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permissive hypotension Intervention | Experimental | In addition to the regular care provided to cardiac surgery patients, those in the permissive hypotension intervention arm will have a MAP target > 60mmHg. |
|
| Standard of Care | No Intervention | Patients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Permissive Hypotension | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MAP in mmHg | (Mean arterial pressure) measured in millimetres of mercury | Through study completion, an average of 2 to 3 days |
| Vasoactive-Inotropic Score for duration of pressor need | Weighted sum of all administered vasopressor and inotropic medications and quantifies the amount of pharmacological support in patients | Through study completion, an average of 2 to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU and hospital length of stay | Total ICU and hospital length of stay following cardiac surgery | Through study completion, an average of a week |
| Duration of inotrope and vasopressor exposure | Total duration of inotrope and vasopressor support required |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30857599 | Background | 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. | |
| 32049269 | Background | 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. |
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| Through study completion, an average of 2 to 3 days |
| Duration of end organ support | Total duration for end organ support | Through study completion, an average of 2 to 3 days |
| Mortality | Occurrence of death during study intervention | Through study completion, an average of a week |
| Cognitive function assessed using Montreal Cognitive Assessment (MOCA) | Brief screening instrument for cognitive function | Through study completion, an average of a week |
| Tissue perfusion pressure via continuous arterial waveform monitoring | Hemodynamic monitoring to ensure optimal tissue perfusion and oxygen delivery | Through study completion, an average of 2 to 3 days |
| 28551721 | Background | 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. |
| 26891677 | Background | 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. |