Vasopressors for Intensive Care

(CEPEC Trial)

Recruiting at 8 trial locations

Overseen By Marie-Helene Masse, RRT, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

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)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

6900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of vasopressors—medications that tighten blood vessels and raise blood pressure—in treating ICU patients with low blood pressure. The trial consists of two parts: one focuses on adjusting blood pressure targets with vasopressors, and the other examines platelet transfusions for ICU patients with low platelet counts requiring certain medical procedures. Patients suitable for the vasopressor part have ongoing low blood pressure treated with these drugs and are expected to remain in the ICU for more than two days. Those interested in the platelet part should have low platelet counts and require an invasive procedure with low to moderate bleeding risk. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that vasopressors, drugs used to raise blood pressure in patients with shock, are generally safe in intensive care. Studies have found that patients tolerate these medications well, even when administered through a vein in the arm. The risk of complications, such as extravasation (when medication leaks into nearby tissue), remains low. Administering vasopressors early in treatment does not appear to increase the risk of death and may benefit patients with conditions like sepsis. Overall, evidence suggests these treatments effectively stabilize blood pressure in critical situations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it aims to optimize the use of vasopressors and platelet transfusions in intensive care unit (ICU) patients, potentially improving patient outcomes. Unlike typical approaches that don't specify precise blood pressure targets or platelet levels for intervention, this trial explores specific thresholds and titration strategies to see if they lead to better results. For vasopressors, the trial examines different blood pressure targets to find the most effective range, while the platelet aspect investigates the best platelet count thresholds for transfusions before procedures. This could lead to more personalized and effective care for ICU patients.

What evidence suggests that this trial's treatments could be effective for intensive care patients?

This trial will evaluate the use of vasopressors in intensive care patients. Studies have shown that vasopressors help control blood pressure in critically ill patients. Research suggests that norepinephrine, a common vasopressor, is recommended for patients with septic shock because it causes fewer heart issues. In one study, 40% of patients with septic shock who received high doses of vasopressors survived 28 days after starting treatment. Another study found that administering vasopressors through a central or peripheral line did not affect survival rates at 90 days. These findings suggest that vasopressors can effectively manage low blood pressure in intensive care patients. ^{2 5 6 7 8}

Who Is on the Research Team?

Neill Adhikari, MDCM, MSc

Principal Investigator

Sunnybrook Research Institute

Francois Lamontagne, MD, MSc

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Vasopressor Experimental Treatment 4 Interventions

Participants will receive vasopressor(s) and their mean arterial pressure will be titrated according to the group they are randomized to (group 1: 56-60 mmHg; group 2: 61-65 mmHg; group 3: 66-70 mmHg; group 4: 71-75 mmHg). Physicians will have the liberty of restricting the randomization to at least 2 contiguous ranges

Group II: Platelet Experimental Treatment 5 Interventions

Thrombocytopenic intensive care unit (ICU) patients (platelet count \<50×109/L) with a planned low-moderate bleeding-risk procedure will be randomized to one of five equally spaced platelet thresholds (less than 10 x 109/L, less than 20 x 109/L, less than 30 x 109/L, less than 40 x 109/L, less than 50 X 109/L) below which they will receive prophylactic platelet transfusions before any low-moderate bleeding-risk procedure occurring during the ICU episode up to ICU day 90. Once randomized, the clinical team will administer a platelet transfusion according to the assigned threshold and the most recent platelet count at the time of the planned procedure.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12240503/

Analyzing outcomes for peripheral versus central ...

This narrative review aims to provide a comprehensive comparison between central and peripheral administration of vasopressor agents, as well as ...

2.

ccforum.biomedcentral.com

ccforum.biomedcentral.com/articles/10.1186/s13054-025-05540-2

Vasopressin and its analogues in patients with septic shock

Norepinephrine is currently recommended as first-line vasopressor in patients with septic shock [5], since norepinephrine induces fewer cardiac ...

3.

annalsofintensivecare.springeropen.com

annalsofintensivecare.springeropen.com/articles/10.1186/s13613-017-0261-x

Outcome of patients with septic shock and high-dose ...

In total, 40% of septic shock patients receiving high-dose vasopressor therapy survived at day 28 after admission. A WMD cutoff value of 0.75 µg ...

4.

journals.lww.com

journals.lww.com/ccmjournal/fulltext/2025/01001/1268__clinical_impact_of_concentrated_vasopressors.1221.aspx

clinical impact of concentrated vasopressors and inotropes ...

This data suggests that patients who may benefit from double concentrating vasopressors are those receiving at least 1 L of volume per day from standard ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2838074

Peripheral Vasopressor Use in Early Sepsis-Induced ...

Peripheral vs central vasopressor initiation was not associated with 90-day mortality in the primary analysis (128 participants [26.1%] vs 34 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10488618/

Safety and Outcomes of Peripherally Administered ...

Conclusions: The administration of vasopressor infusions via PVC for the management of patients with CS is feasible and safe in patients with ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06920173

Pulse Study: Peripheral Use of Low-dose Vasopressors for ...

In the intensive care unit (ICU), vasopressors are administered when fluid resuscitation alone cannot maintain adequate blood pressure in patients with shock.

8.

journals.lww.com

journals.lww.com/ccmjournal/fulltext/2025/01001/1668__safety_of_administration_of_vasopressors.1621.aspx

safety of administration of vasopressors through peripheral ...

Conclusions: While risk of extravasation remains, patients can safely receive multiple vasopressor medications through peripheral IV access given relatively low ...