Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06920173

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston Health Sciences Center

Kingston, Ontario, K7K 2V7, Canada

Location status: Recruiting

Location contact

Dr. Boyd, PhD, MD

CONTACT

[email protected]

613-549-6666 ext. 6228

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experiemental: Peripheral Venous Catheter

Procedure

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.

Primary outcomes

  1. The feasibility of recruitment

    Time frame: 1 week

    We hope to recruit at least 80% of patients who are eligible for the study.

  2. Feasibility of data capture rate

    Time frame: 1 week

    We hope to have a data capture rate of at least 90%

  3. 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

Secondary outcomes

  1. 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.

  2. Assessing extravasation rates

    Time frame: 1 week

    This will be reported using descriptive statistics with a confidence interval of 95%.

  3. Assessing alive and central line-free days

    Time frame: 1 week

    This will be reported as medians with a 95% confidence interval.

  4. Assessing central-line associated blood stream infections

    Time frame: 1 week

    This will be reported as medians with a 95% confidence interval.

  5. Assessing mortality rate

    Time frame: 1 week

    This will be reported as medians with a 95% confidence interval.

  6. Assessing ICU and hospital length of stay

    Time frame: 1 week

    This will be reported as medians with a 95% confidence interval.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Boyd, PhD, MD

CONTACT

[email protected]

613-549-6666 ext. 6228

Dr. Wiseman, MD

CONTACT

[email protected]

613-859-6486

Sponsors and collaborators

Lead sponsor

Kingston Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: PULSE

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.