The Peripheral Use of Low-dose Vasopressors for Safety and Efficacy (PULSE) in the intensive care unit: a prospective, unblinded feasibility study protocol

ABSTRACT

Introduction There is increasing interest in the peripheral administration of vasopressors for two main reasons: (1) to expedite vasopressor initiation in patients with refractory shock and (2) to avoid the potential complications associated with central venous catheter placement. The current evidence on the use of peripheral vasopressor administration is primarily based on single-center observational studies. There are inconsistencies in the administration of peripheral vasopressors, including catheter gauge and location, monitoring practices, vasopressor concentrations, and duration of use. This has made it difficult for institutions to develop best practice guidelines. A randomized controlled trial is needed to address this knowledge gap.

Methods and analysis The Peripheral Use of Low-dose Vasopressors for Safety and Efficacy (PULSE) in the intensive care unit is a prospective, unblinded feasibility study. Eligible patients will be 18 years or older, have no existing central venous catheter or peripherally inserted central catheter and have the presence of shock requiring a minimum vasopressor dose of any of the following: norepinephrine 0.0625 mcg/kg/min, phenylephrine 0.625 mcg/kg/min, and epinephrine 0.0625 mcg/kg/min. Fifty patients will be randomized 1:1 into either the peripheral venous catheter or central venous catheter group. The primary outcome is feasibility, defined as (1) a recruitment rate of 4 participants per month, (2) a data capture rate of ≥90%, and (3) a <50% conversion rate from peripheral to central access. The secondary outcomes include the safety of peripheral vasopressor use, alive and central-line-free days, the number of attempts needed to place a catheter, volume status, in-hospital mortality rate, ICU and hospital length of stay, and patient-centred important outcomes.

Implications The data collected from this study will inform the design of a definitive randomized controlled trial to assess the safety and efficacy of protocol-driven peripheral vasopressor administration.

Ethics and dissemination This study received approval (6042888) from the Queen’s University Health Sciences/Affiliated Teaching Hospitals Research Ethics Boards. Results of this study will be presented at critical care conferences and submitted for publication.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06920173

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee of Queen's University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board, DMED (6042888).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

Contact Information: Jessica Wiseman, Department of Critical Care Medicine, Queen’s University/Kingston General Hospital, 76 Stuart Street, Kingston, Ontario, K7L 2V7, 8jfw2queensu.ca

Funding: This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors

Competing interests: none declared

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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