Recruiting
Phase 2

Vasopressors

Sponsor:

Kingston Health Sciences Centre

Code:

NCT06920173

Conditions

Shock

Peripheral Venous Catheterization

Central Venous Catheterization

Critically Ill Patients Admitted in ICU

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experiemental: Peripheral Venous Catheter

Study Details

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

Study ID

NCT06920173

Start date

Feb 3, 2025

Status verified date

Apr, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Peripheral Venous Catheter

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.

active comparator: Central Venous Catheter

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

Interventions

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.

Primary outcome measure

  • The feasibility of recruitment [ Time Frame: 1 week ]
  • Feasibility of data capture rate [ Time Frame: 1 week ]
  • Feasibility of acceptability rate of peripheral vasopressor protocol [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Locations

Kingston Health Sciences Center

Recruiting

Kingston, Ontario, Canada, K7K 2V7

Contacts

More Information

Sponsor

Kingston Health Sciences Centre

Last update posted

Apr 9, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kingston Health Sciences Centre on 2025-04-09.