Permissive Hypotension After Cardiac Surgery

NCT06476613 | Active Not Recruiting DMC

• 1 other identifier: 2023P003142
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• ICU and hospital length of stay

  Through study completion, an average of a week

• Duration of inotrope and vasopressor exposure

  Through study completion, an average of 2 to 3 days

• Duration of end organ support

  Through study completion, an average of 2 to 3 days

• Mortality

  Through study completion, an average of a week

• Cognitive function assessed using Montreal Cognitive Assessment (MOCA)

  Through study completion, an average of a week

Study Arms (2)

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.

Other: Permissive Hypotension

Standard of Care

NO INTERVENTION

Patients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients.

Interventions

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.

Permissive hypotension Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Schedules for elective or non-emergent cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 30857599 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.

  PMID: 32049269 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.

  PMID: 28551721 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.

  PMID: 26891677 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 26, 2024
• Study Start: April 20, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)