Vasopressors for Intensive Care

(CEPEC Trial)

Overseen By Marie-Helene Masse, RRT, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must be taking: Vasopressors

Disqualifiers: Brain injury, Hemorrhage, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

6500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the drug vasopressors for intensive care?

Vasopressors are used to increase blood pressure in emergency situations, helping deliver oxygen and nutrients to vital organs. Norepinephrine is often preferred for treating low blood pressure in conditions like septic shock, although no single vasopressor has shown a clear survival advantage over others. ^{1 2 3 4 5}

Is vasopressor treatment generally safe for humans?

Vasopressors are used to raise blood pressure in critical care, but they can have side effects like reduced blood flow and increased risk of death, especially in older patients. Different vasopressors have varying effects, and while they are necessary in emergencies, their use must be carefully balanced to avoid adverse outcomes. ^{2 3 5 6 7}

How is the vasopressor treatment different from other treatments for low blood pressure in intensive care?

Vasopressors are unique because they are powerful medications used to quickly raise blood pressure in critical situations, often administered intravenously in the ICU. Unlike some treatments, oral vasopressors like midodrine are being explored to reduce the need for ICU admission by potentially replacing IV vasopressors in certain cases. ^{2 3 8 9 10}

What is the purpose of this trial?

The Canadian Critical Care Comparative Effectiveness Platform(e) d'Évaluation Clinique Comparée en soins Critiques (CEPEC) is an international multi-centered randomized adaptive platform clinical trial. CEPEC will evaluate supportive care interventions that are used routinely in intensive care units throughout the world.

Research Team

Francois Lamontagne, MD, MSc

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

This trial is for ICU patients expected to stay over 48 hours, with a mean arterial pressure (MAP) under 75 mmHg needing vasopressors for low blood pressure. It's not for those with recent severe brain or spinal injuries, imminent death within a day, palliative care goals, or if they've been in the ICU too long before joining.

Inclusion Criteria

Patient expected to be in the ICU for more than 48 hours

I am currently admitted to an ICU that is part of the study.

My blood pressure has been below 75 mmHg.

Exclusion Criteria

I had a bleeding in my brain less than 3 weeks ago.

Death predicted by the treating team to occur within 24 hours

Treating team does not have equipoise for at least two contiguous MAP target ranges in the CEPEC Vasopressor Domain

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive supportive care interventions, including vasopressors, in the ICU setting

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of persistent organ dysfunction and disposition at hospital discharge

Up to 30 days

Treatment Details

Interventions

• Vasopressors

Trial Overview The study tests different levels of blood pressure control using vasopressors in ICU patients. Participants are randomly assigned to one of four groups targeting specific MAP ranges: 56-60, 61-65, 66-70, or 71-75 mmHg.

Participant Groups

Group I: Vasopressors Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Findings from Research

Vasopressors are critical medications used to increase blood pressure in emergencies, with norepinephrine being a preferred choice for conditions like cardiogenic and septic shock due to its effectiveness in maintaining organ perfusion.

Current evidence does not show a clear mortality benefit for any specific vasopressor over others, indicating that the choice of vasopressor often depends on clinical circumstances and physician preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasopressor use in adult patients. Ferguson-Myrthil, N.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does high-dose vasopressor therapy in medical intensive care patients indicate what we already suspect? [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Vasopressor use in adult patients. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of Reduced Exposure to Vasopressors on 90-Day Mortality in Older Critically Ill Patients With Vasodilatory Hypotension: A Randomized Clinical Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Realistic Survival Outcomes After Vasopressor Use in the Intensive Care Unit. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Lower Versus Higher Exposure to Vasopressor Therapy in Vasodilatory Hypotension: A Systematic Review With Meta-Analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Reduced exposure to vasopressors through permissive hypotension to reduce mortality in critically ill people aged 65 and over: the 65 RCT. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Current use of vasopressors in septic shock. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Vasopressor therapy in critically ill patients with shock. [2020]

9. England pubmed.ncbi.nlm.nih.gov

LIBERATE: a study protocol for midodrine for the early liberation from vasopressor support in the intensive care unit (LIBERATE): protocol for a randomized controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Temporal trends in the utilization of vasopressors in intensive care units: an epidemiologic study. [2018]