Peripheral Vasopressors for Intensive Care Unit Patients

(PULSE Trial)

Overseen By Dr. Wiseman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kingston Health Sciences Centre

Must be taking: Vasopressors

Disqualifiers: Dialysis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of using peripheral venous catheters for administering vasopressors in ICU patients?

Research suggests that using peripheral venous catheters to administer vasopressors can be a safe and effective alternative to central venous catheters, especially in urgent situations like septic shock, as it avoids the time and complications associated with central access. ^{1 2 3 4 5}

Is it safe to administer vasopressors through a peripheral venous catheter?

Recent studies suggest that administering vasopressors through a peripheral venous catheter (PVC) can be a safe alternative to central venous catheters (CVCs), with a low incidence of complications like extravasation (leakage of medication into surrounding tissue). In a review of 202 patients, only 4% experienced extravasation, and all cases were managed without the need for surgery or antidotes. ^{6 7 8 9 10}

How is the peripheral administration of vasopressors different from other treatments for ICU patients?

Peripheral administration of vasopressors, like norepinephrine and phenylephrine, is unique because it uses a peripheral venous catheter (a small tube inserted into a vein in the arm) instead of a central venous catheter (a larger tube placed in a major vein), which is traditionally used. This method can be quicker and avoids the complications associated with central venous access, making it a potentially safer and more convenient option for patients who cannot have a central line. ^{2 4 5 6 11}

What is the purpose of 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.

Research Team

Gord Dr., PhD, MD

Principal Investigator

Queen's University, Kingston Health Sciences Center

Eligibility Criteria

This trial is for ICU patients who need blood pressure support due to shock and are undergoing procedures like central line insertion. It's not suitable for those with conditions that prevent safe participation or where peripheral vasopressor use is contraindicated.

Inclusion Criteria

I am on strong medication to maintain my blood pressure due to shock.

I am 18 or older and do not have a central or PICC line.

Exclusion Criteria

I need urgent dialysis and require a catheter for it.

I needed more than two medications to maintain my blood pressure when admitted to the ICU.

Pregnancy or suspected pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Feasibility Study

Implementation of a peripheral vasopressor protocol and assessment of recruitment feasibility, data capture rate, and acceptability rate by healthcare providers

8 weeks

Weekly assessments

Safety Assessment

Assessment of safety of peripheral vasopressor administration, capturing adverse events such as extravasation, pneumothorax, and deep vein thrombosis

2 months

Follow-up

Participants are monitored for clinically relevant outcomes such as alive and central line-free days, infection rates, and mortality

1 week

Treatment Details

Interventions

• Peripheral Venous Catheter

Trial Overview The study tests the safety and effectiveness of using a Peripheral Venous Catheter (PVC) for administering low-dose vasopressors, which typically require a Central Venous Catheter (CVC), in order to reduce CVC-related complications.

Participant Groups

Group I: Peripheral Venous Catheter Experimental Treatment 1 Intervention

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.

Group II: Central Venous Catheter Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Kingston Health Sciences Centre

Lead Sponsor

Trials

32

Recruited

34,400+

Kingston Health Sciences Centre

Lead Sponsor

Trials

312

Recruited

112,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Does high-dose vasopressor therapy in medical intensive care patients indicate what we already suspect? [2015]

2. India pubmed.ncbi.nlm.nih.gov

Viewpoint: Weak Scientific Basis for the Recommendation of Executive Summary of Surviving Sepsis Campaign Guidelines 2021. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Initiation of vasopressor infusions via peripheral versus central access in patients with early septic shock: A retrospective cohort study. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Outcomes of Peripherally Administered Vasopressor Infusion in Patients Admitted with Shock to an Intensive Cardiac Care Unit-A Single-Center Prospective Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Complications from Administration of Vasopressors Through Peripheral Venous Catheters: An Observational Study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of the Peripheral Administration of Vasopressor Agents. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Safety of peripheral administration of vasopressor medications: A systematic review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with administration of vasopressor medications through a peripheral intravenous catheter: a systematic review and meta-analysis. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Complication of vasopressor infusion through peripheral venous catheter: A systematic review and meta-analysis. [2021]

10. Poland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Peripheral Intravenous Administration of Vasopressor Agents in Resource-limited Settings. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of vasopressor administration through midline catheters. [2022]