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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKingston Health Sciences Centre

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experiemental: Peripheral Venous Catheter

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Peripheral Venous CatheterExperimental treatment 1 intervention
Group B: Central Venous CatheterActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The feasibility of recruitment

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

Time frame
1 week
2

Feasibility of data capture rate

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

Time frame
1 week
3

Feasibility of acceptability rate of peripheral vasopressor protocol

We hope to have an acceptability rate of at least 90% by providers and nurses

Time frame
1 week

Secondary outcomes

1

Avoidance of central venous catheter placement

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.

Time frame
1 week
2

Assessing extravasation rates

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

Time frame
1 week
3

Assessing alive and central line-free days

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

Time frame
1 week
4

Assessing central-line associated blood stream infections

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

Time frame
1 week

Other outcomes

Sponsors and contacts

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