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

NCT06920173 | Recruiting Phase 2

• 1 other identifier: 6042888
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shock; Peripheral Venous Catheterization; Central Venous Catheterization; Critically Ill Patients Admitted in ICU

Keywords

critical illness; peripheral vasopressor use; intensive care unit; feasibility study; peripheral venous catheter; central venous catheter

Outcome Measures

Primary Outcomes (3)

• The feasibility of recruitment

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

  1 week

• Feasibility of data capture rate

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

  1 week

• Feasibility of acceptability rate of peripheral vasopressor protocol

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

  1 week

Secondary Outcomes (6)

• Avoidance of central venous catheter placement

  1 week

• Assessing extravasation rates

  1 week

• Assessing alive and central line-free days

  1 week

• Assessing central-line associated blood stream infections

  1 week

• Assessing mortality rate

  1 week

Study Arms (2)

Peripheral Venous Catheter

EXPERIMENTAL

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

Central Venous Catheter

ACTIVE COMPARATOR

Patients in this group will have vasopressors infusing through a central venous catheter

Procedure: Experiemental: Peripheral Venous Catheter

Interventions

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.

Central Venous Catheter; Peripheral Venous Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kingston Health Sciences Centre: lead

Study Sites (1)

Kingston Health Sciences Center

Kingston, Ontario, K7K 2V7, Canada

RECRUITING

Related Publications (9)

• Marti K, Hartley C, Sweeney E, Mah J, Pugliese N. Evaluation of the safety of a novel peripheral vasopressor pilot program and the impact on central line placement in medical and surgical intensive care units. Am J Health Syst Pharm. 2022 Aug 19;79(Suppl 3):S79-S85. doi: 10.1093/ajhp/zxac144.

  PMID: 35605137 BACKGROUND

• Loubani OM, Green RS. A systematic review of extravasation and local tissue injury from administration of vasopressors through peripheral intravenous catheters and central venous catheters. J Crit Care. 2015 Jun;30(3):653.e9-17. doi: 10.1016/j.jcrc.2015.01.014. Epub 2015 Jan 22.

  PMID: 25669592 BACKGROUND

• Munroe ES, Heath ME, Eteer M, Gershengorn HB, Horowitz JK, Jones J, Kaatz S, Tamae Kakazu M, McLaughlin E, Flanders SA, Prescott HC. Use and Outcomes of Peripheral Vasopressors in Early Sepsis-Induced Hypotension Across Michigan Hospitals: A Retrospective Cohort Study. Chest. 2024 Apr;165(4):847-857. doi: 10.1016/j.chest.2023.10.027. Epub 2023 Oct 26.

  PMID: 37898185 BACKGROUND

• McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.

  PMID: 12646670 BACKGROUND

• Stolz A, Efendy R, Apte Y, Craswell A, Lin F, Ramanan M. Safety and efficacy of peripheral versus centrally administered vasopressor infusion: A single-centre retrospective observational study. Aust Crit Care. 2022 Sep;35(5):506-511. doi: 10.1016/j.aucc.2021.08.005. Epub 2021 Sep 30.

  PMID: 34600834 BACKGROUND

• Kalinoski M, Kalinoski T, Pendleton K. The use of peripheral vasopressors and its implications for hospital medicine. Br J Hosp Med (Lond). 2024 Jul 30;85(7):1-8. doi: 10.12968/hmed.2024.0048. Epub 2024 Jul 24.

  PMID: 39078910 BACKGROUND

• Abu Sardaneh A, Penm J, Oliver M, Gattas D, McLachlan AJ, James C, Cella C, Aljuhani O, Acquisto NM, Patanwala AE. International pharmacy survey of peripheral vasopressor infusions in critical care (INFUSE). J Crit Care. 2023 Dec;78:154376. doi: 10.1016/j.jcrc.2023.154376. Epub 2023 Aug 2.

  PMID: 37536012 BACKGROUND

• Owen VS, Rosgen BK, Cherak SJ, Ferland A, Stelfox HT, Fiest KM, Niven DJ. Adverse events associated with administration of vasopressor medications through a peripheral intravenous catheter: a systematic review and meta-analysis. Crit Care. 2021 Apr 16;25(1):146. doi: 10.1186/s13054-021-03553-1.

  PMID: 33863361 BACKGROUND

• Yerke JR, Mireles-Cabodevila E, Chen AY, Bass SN, Reddy AJ, Bauer SR, Kokoczka L, Dugar S, Moghekar A. Peripheral Administration of Norepinephrine: A Prospective Observational Study. Chest. 2024 Feb;165(2):348-355. doi: 10.1016/j.chest.2023.08.019. Epub 2023 Aug 21.

  PMID: 37611862 BACKGROUND

MeSH Terms

Conditions

Shock; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Gord Dr., PhD, MD

  Queen's University, Kingston Health Sciences Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Boyd, PhD, MD

CONTACT

613-549-6666; gordon.boyd@kingstonhsc.ca

Dr. Wiseman, MD

CONTACT

613-859-6486; 8jfw2@queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The proposed study design is a prospective, pragmatic, unblinded feasibility study.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 9, 2025
• Study Start: February 3, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)