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

April 2, 2025 updated by: Dr. Gordon Boyd, Kingston Health Sciences Centre

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

Using medications to increase blood pressure, called vasopressors, is invaluable in treating patients who have difficulty maintaining stable blood pressure. Vasopressors are usually infused through a central venous catheter (CVC), which is a flexible tube placed in the large vein of the neck, arm or groin. CVCs require a skilled clinician and often with an ultrasound to prevent complications such as a collapsed lung or bleeding. Alternatively, the infusion of vasopressors through a peripheral venous catheter (PVC), a thin tube placed in the smaller veins of the arm or hand has been avoided due to the risk of extravasation, which is the leakage of fluid to surrounding tissues. This can lead to potential tissue death requiring surgery. However, emerging research shows the safety of infusing vasopressors through a PVC, referred to as peripheral vasopressors. There is a growing interest in peripheral vasopressors for two main reasons: to expedite vasopressor initiation in patients with refractory shock and to avoid CVC placement and its potential complications. However, a standardized protocol for administration is lacking and many clinicians still avoid peripheral vasopressors due to lack of high-quality evidence. The investigators will examine the effectiveness of implementing a peripheral vasopressor protocol by conducting a feasibility study and assessing outcomes such as the safety of peripheral vasopressors and the acceptability rate of healthcare providers. By conducting this study, the investigators aim to provide the framework to conduct larger, multi-center trials and to provide high-quality data for the future use of a standardized peripheral vasopressor protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the intensive care unit (ICU), vasopressors are administered when fluid resuscitation alone cannot maintain adequate blood pressure in patients with shock. The standard of care for continuous infusions of vasopressors is through a central venous catheter (CVC) rather than a peripheral venous catheter (PVC). The use of CVCs prevents extravasation, which can lead to local tissue ischemia resulting in necrosis. However, CVC placement is not a benign procedure requiring a skilled clinician and the use of ultrasound guidance to prevent complications such as pneumothorax, bleeding or erroneous arterial cannulation. Furthermore, complications related to the maintenance of CVCs include deep vein thrombosis (DVT), and central line-associated blood stream infections (CLABSIs). These recognized complications occur in more than 15% of patients. There is a growing interest in peripheral vasopressor use for two main reasons: to expedite vasopressor administration in patients with refractory shock and to potentially avoid CVC placement and it complications. However, there remains no standardized protocols and many clinicians still believe that vasopressors must be infused through a CVC despite current evidence showing the safety of peripheral vasopressors. However, to date only observational studies have been performed. A randomized control trial is needed to provide high quality data to improve the future use of peripheral vasopressors, which has the potential to positively impact patient care.

The investigators will perform a feasibility study for the implementation of a peripheral vasopressor protocol. They will also assess the safety of the peripheral vasopressor protocol and evaluate clinically relevant outcomes, which will be listed below. The investigators hypothesize that implementing a peripheral vasopressor protocol is feasible and safe.

Aim 1: Adapt a peripheral vasopressor protocol and perform a feasibility study. The investigators will conduct a feasibility study to determine the efficacy of a peripheral vasopressor protocol. In collaboration with an ICU pharmacist, the investigators will adopt a peripheral vasopressor protocol at Kingston Health Sciences Center to determine the dosages and concentrations of each vasopressor. The participants will be randomized 1:1:1 into a low-dose peripheral vasopressor group vs. a dose peripheral vasopressor group vs a high-dose peripheral vasopressor group vs a CVC group. Based on the admission rates of our ICU, the investigators aim to recruit 25 patients into each group. They will investigate the feasibility of recruitment, data capture rate, acceptability rate by nursing staff and providers of the peripheral vasopressor protocol and avoidance rate of CVC placement.

Aim 2a: Perform a safety assessment of peripheral vasopressor protocol. The investigators will assess the safety of peripheral vasopressor administration after two months of protocol initiation. Specific adverse events to be captured include extravasation (+/- tissue necrosis), pneumothorax, arterial cannulation, and deep vein thrombosis. The investigators will assess any differences in adverse events between the low-dose peripheral vasopressor group vs the high-dose peripheral vasopressor group vs the CVC group, which will be reported as proportions. The investigators hypothesize that peripheral vasopressor use will be safe compared to the CVC group, with few to no adverse events.

Aim 2b: Determine the impact of a peripheral vasopressor protocol on clinically relevant outcomes. This feasibility study will investigate secondary outcomes such as alive and central line-free days, infection rates including CLABSIs, mortality and ICU/hospital length of stay. The investigators will report these outcomes as medians with 95% confidence intervals.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7K 2V7
        • Recruiting
        • Kingston Health Sciences Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 mc/min, dobutamine 5 mcg/kg/min

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral Venous Catheter
Patients in this arm will have vasopressors infusing through a peripheral venous catheter. If patients have escalating doses of vasopressors or require more than 2 vasopressors, they will have a central venous catheter placed.
Procedure: Experiemental: Peripheral Venous Catheter
Patients older than 18 years of age who present with shock requiring vasopressors at the following minimum doses: norepinephrine 5 mcg/min, phenylephrine 50 mcg/min, epinephrine 5 mc/min, dobutamine 5 mcg/kg/min. Vasopressors are infused through a peripheral venous catheter (18 gauge or larger); however, patients are crossed over to the central venous catheter group if the maximum vasopressor dose is reached or more than two vasopressors.
Active Comparator: Central Venous Catheter
Patients in this group will have vasopressors infusing through a central venous catheter
Procedure: Experiemental: Peripheral Venous Catheter
Patients older than 18 years of age who present with shock requiring vasopressors at the following minimum doses: norepinephrine 5 mcg/min, phenylephrine 50 mcg/min, epinephrine 5 mc/min, dobutamine 5 mcg/kg/min. Vasopressors are infused through a peripheral venous catheter (18 gauge or larger); however, patients are crossed over to the central venous catheter group if the maximum vasopressor dose is reached or more than two vasopressors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The feasibility of recruitment
Time Frame: 1 week
We hope to recruit at least 80% of patients who are eligible for the study.
1 week
Feasibility of data capture rate
Time Frame: 1 week
We hope to have a data capture rate of at least 90%
1 week
Feasibility of acceptability rate of peripheral vasopressor protocol
Time Frame: 1 week
We hope to have an acceptability rate of at least 90% by providers and nurses
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoidance of central venous catheter placement
Time Frame: 1 week
We will evaluate the crossover rate in patients who are initiated on peripheral vasopressors but ultimately require a central line due to escalating doses of vasopressors or poor venous access. We hope that 50% of patients will need a central line who have been initially allocated to the PVC group.
1 week
Assessing extravasation rates
Time Frame: 1 week
This will be reported using descriptive statistics with a confidence interval of 95%.
1 week
Assessing alive and central line-free days
Time Frame: 1 week
This will be reported as medians with a 95% confidence interval.
1 week
Assessing central-line associated blood stream infections
Time Frame: 1 week
This will be reported as medians with a 95% confidence interval.
1 week
Assessing mortality rate
Time Frame: 1 week
This will be reported as medians with a 95% confidence interval.
1 week
Assessing ICU and hospital length of stay
Time Frame: 1 week
This will be reported as medians with a 95% confidence interval.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kingston Health Sciences Centre

Investigators

  • Principal Investigator: Gord Dr., PhD, MD, Queen's University, Kingston Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6042888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data that will be shared include age, sex, admission date and admitting diagnosis, peripheral IV location and gauge, vasopressor type, duration of vasopressor and complications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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