Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06920173

The PULSE Study - Peripheral Use of Low-dose Vasopressors for Safety and Efficacy in the Intensive Care Unit: a Pilot Feasibility Study

Led by Kingston Health Sciences Centre · Updated on 2025-04-09

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of vasopressors, medications that raise blood pressure, in critically ill patients with shock who need help maintaining stable blood pressure. Typically, vasopressors are given through a central venous catheter (CVC), a tube placed in a large vein, but this approach requires skilled clinicians and can cause serious complications. This study explores the safety and feasibility of using peripheral venous catheters (PVCs), thinner tubes placed in smaller veins, to deliver vasopressors, aiming to provide high-quality data to support a standardized peripheral vasopressor protocol. The study involves randomly assigning patients to receive vasopressors either through a peripheral venous catheter at varying dose levels or through a central venous catheter. Patients in the peripheral group may be switched to a central line if they require high doses or multiple vasopressors. The investigators will adapt and implement a peripheral vasopressor protocol with ICU pharmacists to determine appropriate dosages and concentrations. This pilot feasibility study will recruit about 25 patients per group to assess protocol feasibility, safety outcomes, and healthcare provider acceptance. Participants will be monitored for safety issues such as leakage of medication into surrounding tissues, lung collapse, arterial puncture, and blood clots. Researchers will also track outcomes like avoidance of central line placement, infection rates, survival, and length of ICU and hospital stay. The study includes collecting data on recruitment success, data capture, and staff acceptance over a one-week period. The overall study period extends until June 2026, with ongoing assessments to inform future larger trials.

CONDITIONS

Brief Title

Pulse Study: Peripheral Use of Low-dose Vasopressors for Safety and Efficacy in the Intensive Care Unit

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 or older who do not have a central line or PICC line already placed
  • Presence of shock requiring vasopressors at the following minimum doses: norepinephrine 5 mcg/min, phenylephrine 50 mcg/min, epinephrine 5 mcg/min, dobutamine 5 mcg/kg/min
Not Eligible

You will not qualify if you...

  • Urgent need for dialysis requiring placement of hemodialysis catheter
  • More than two vasopressors are required to maintain a mean arterial pressure above 65 on admission to the ICU
  • Pregnancy or suspected pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 week

Participants receive vasopressors through either a peripheral venous catheter or a central venous catheter according to their randomized group. If vasopressor doses escalate or more than two vasopressors are required, participants in the peripheral venous catheter group may be switched to the central venous catheter group.

Continuous care during ICU stay with monitoring

Follow-up

Duration - Up to 1 week after treatment

Participants are monitored for safety outcomes including extravasation, pneumothorax, arterial cannulation, deep vein thrombosis, infections, mortality, and length of ICU and hospital stay.

Ongoing assessments during hospital stay

Trial Site Locations

Total: 1 location

1

Kingston Health Sciences Center

Kingston, Ontario, Canada, K7K 2V7

Actively Recruiting

Loading map...

Research Team

D

Dr. Boyd, PhD, MD

D

Dr. Wiseman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Acutelines: a Large Biobank Aiming to Improve Early Recognit...

Acute Disease

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Evaluation of the safety of a novel peripheral vasopressor pilot program and the impact on central line placement in medical and surgical intensive care units.

Kristen Marti, Christopher Hartley, Elizabeth Sweeney...

https://pubmed.ncbi.nlm.nih.gov/35605137

A systematic review of extravasation and local tissue injury from administration of vasopressors through peripheral intravenous catheters and central venous catheters.

Osama M Loubani, Robert S Green

https://pubmed.ncbi.nlm.nih.gov/25669592

Use and Outcomes of Peripheral Vasopressors in Early Sepsis-Induced Hypotension Across Michigan Hospitals: A Retrospective Cohort Study.

Elizabeth S Munroe, Megan E Heath, Mousab Eteer...

https://pubmed.ncbi.nlm.nih.gov/37898185

Safety and efficacy of peripheral versus centrally administered vasopressor infusion: A single-centre retrospective observational study.

Annaliese Stolz, Rachel Efendy, Yogesh Apte...

https://pubmed.ncbi.nlm.nih.gov/34600834

Adverse events associated with administration of vasopressor medications through a peripheral intravenous catheter: a systematic review and meta-analysis.

Victoria S Owen, Brianna K Rosgen, Stephana J Cherak...

https://pubmed.ncbi.nlm.nih.gov/33863361