Home/Get Matched/NCT06920173
Phase 2Recruiting
View on ClinicalTrials.gov

Testing Experiemental: Peripheral Venous for shock

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

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

Condition: ShockSponsor: Kingston Health Sciences CentreTarget enrollment: 50
  • Phase 2
  • 2 groups
  • One site, in Kingston
  • Recruiting
Kingston Health Sciences Center, Kingston, Ontario

Interventions

  • Medical 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.

Canadian Sites (1)

1 of 1 recruiting

  • Kingston Health Sciences Center

    Kingston, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for5 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +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

  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Experiemental: Peripheral Venous Catheter.

Registry label: A: Peripheral Venous Catheter

Group B, the comparison group, receives Experiemental: Peripheral Venous Catheter.

Registry label: B: Central Venous Catheter

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 50 people.

The study is currently expected to finish around June 2026.

The main measurement is taken over: 1 week.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

The feasibility of recruitment — measured over 1 week.

Feasibility of data capture rate — measured over 1 week.

Feasibility of acceptability rate of peripheral vasopressor protocolProtocolThe detailed plan a study must follow.Read more → — measured over 1 week.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06920173 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Experiemental: Peripheral Venous CatheterProcedure

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.

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 1 week.

The study as a whole is currently expected to finish around 2026-06-30.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 50 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Kingston, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.