ShockPhase 2PULSENCT06920173
Pulse Study: Peripheral Use of Low-dose Vasopressors for Safety and Efficacy in the Intensive Care Unit
A Phase 2 study testing Experiemental: Peripheral Venous Catheter in people with Shock and Peripheral Venous Catheterization, run by Kingston Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Peripheral Venous Catheterization, Central Venous Catheterization
- What is being tested?
- Experiemental: Peripheral Venous Catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2025to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Kingston Health Sciences Center
Kingston, Ontario, K7K 2V7
Dr. Boyd, PhD, MD, 613-549-6666 ext. 6228, gordon.boyd@kingstonhsc.ca
About this study
Official title: The PULSE Study - The Peripheral Use of Low-dose Vasopressors for Safety and Efficacy in the Intensive Care Unit: a Pilot Feasibility Study
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.
Read the detailed description
In the intensive care unit (ICU), vasopressors are administered when fluid resuscitation alone cannot maintain adequate blood pressure in patients with shock. The standard of care for continuous infusions of vasopressors is through a central venous catheter (CVC) rather than a peripheral venous catheter (PVC). The use of CVCs prevents extravasation, which can lead to local tissue ischemia resulting in necrosis. However, CVC placement is not a benign procedure requiring a skilled clinician and the use of ultrasound guidance to prevent complications such as pneumothorax, bleeding or erroneous arterial cannulation. Furthermore, complications related to the maintenance of CVCs include deep vein thrombosis (DVT), and central line-associated blood stream infections (CLABSIs). These recognized complications occur in more than 15% of patients. There is a growing interest in peripheral vasopressor use for two main reasons: to expedite vasopressor administration in patients with refractory shock and to potentially avoid CVC placement and it complications. However, there remains no standardized protocols and many clinicians still believe that vasopressors must be infused through a CVC despite current evidence showing the safety of peripheral vasopressors. However, to date only observational studies have been performed. A randomized control trial is needed to provide high quality data to improve the future use of peripheral vasopressors, which has the potential to positively impact patient care.
The investigators will perform a feasibility study for the implementation of a peripheral vasopressor protocol. They will also assess the safety of the peripheral vasopressor protocol and evaluate clinically relevant outcomes, which will be listed below. The investigators hypothesize that implementing a peripheral vasopressor protocol is feasible and safe.
Aim 1: Adapt a peripheral vasopressor protocol and perform a feasibility study. The investigators will conduct a feasibility study to determine the efficacy of a peripheral vasopressor protocol. In collaboration with an ICU pharmacist, the investigators will adopt a peripheral vasopressor protocol at Kingston Health Sciences Center to determine the dosages and concentrations of each vasopressor. The participants will be randomized 1:1:1 into a low-dose peripheral vasopressor group vs. a dose peripheral vasopressor group vs a high-dose peripheral vasopressor group vs a CVC group. Based on the admission rates of our ICU, the investigators aim to recruit 25 patients into each group. They will investigate the feasibility of recruitment, data capture rate, acceptability rate by nursing staff and providers of the peripheral vasopressor protocol and avoidance rate of CVC placement.
Aim 2a: Perform a safety assessment of peripheral vasopressor protocol. The investigators will assess the safety of peripheral vasopressor administration after two months of protocol initiation. Specific adverse events to be captured include extravasation (+/- tissue necrosis), pneumothorax, arterial cannulation, and deep vein thrombosis. The investigators will assess any differences in adverse events between the low-dose peripheral vasopressor group vs the high-dose peripheral vasopressor group vs the CVC group, which will be reported as proportions. The investigators hypothesize that peripheral vasopressor use will be safe compared to the CVC group, with few to no adverse events.
Aim 2b: Determine the impact of a peripheral vasopressor protocol on clinically relevant outcomes. This feasibility study will investigate secondary outcomes such as alive and central line-free days, infection rates including CLABSIs, mortality and ICU/hospital length of stay. The investigators will report these outcomes as medians with 95% confidence intervals.
- Conditions
- Shock, Peripheral Venous Catheterization, Central Venous Catheterization, Critically Ill Patients Admitted in ICU
- Being tested
- Experiemental: Peripheral Venous Catheter
- Keywords
- critical illness, peripheral vasopressor use, intensive care unit, feasibility study, peripheral venous catheter, central venous catheter
- Medical subject headings
- Shock, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experiemental: Peripheral Venous CatheterProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Experiemental: Peripheral Venous Catheter |
| Central Venous Catheter | Active comparator | Patients in this group will have vasopressors infusing through a central venous catheter Receives: Procedure: Experiemental: Peripheral Venous Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of recruitment
We hope to recruit at least 80% of patients who are eligible for the study.
Measured: 1 week
Feasibility of data capture rate
We hope to have a data capture rate of at least 90%
Measured: 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
Measured: 1 week
Secondary outcomes (6)
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.
Measured: 1 week
Assessing extravasation rates
This will be reported using descriptive statistics with a confidence interval of 95%.
Measured: 1 week
Assessing alive and central line-free days
This will be reported as medians with a 95% confidence interval.
Measured: 1 week
Assessing central-line associated blood stream infections
This will be reported as medians with a 95% confidence interval.
Measured: 1 week
Assessing mortality rate
This will be reported as medians with a 95% confidence interval.
Measured: 1 week
Assessing ICU and hospital length of stay
This will be reported as medians with a 95% confidence interval.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start3 Feb 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study design is a prospective, pragmatic, unblinded feasibility study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kingston Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gordon Boyd, Kingston Health Sciences Centre
- Investigators
- Gord Dr., PhD, MD, Principal investigator, Queen's University, Kingston Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920173
- Sponsor's protocol ID
- 6042888
- Acronym
- PULSE
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that will be shared include age, sex, admission date and admitting diagnosis, peripheral IV location and gauge, vasopressor type, duration of vasopressor and complications.
Publications
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.
PubMed 35605137Loubani 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.
PubMed 25669592Munroe 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.
PubMed 37898185McGee 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.
PubMed 12646670Stolz 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.
PubMed 34600834Kalinoski 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.
PubMed 39078910Abu 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.
PubMed 37536012Owen 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.
PubMed 33863361Yerke 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.
PubMed 37611862
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PULSE Study - The Peripheral Use of Low-dose Vasopressors for Safety and Efficacy in the Intensive Care Unit: a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06920173
- Acronym / sponsor ID
- PULSE / 6042888
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kingston Health Sciences CentreUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the intensive care unit (ICU), vasopressors are administered when fluid resuscitation alone cannot maintain adequate blood pressure in patients with shock. The standard of care for continuous infusions of vasopressors is through a central venous catheter (CVC) rather than a peripheral venous catheter (PVC). The use of CVCs prevents extravasation, which can lead to local tissue ischemia resulting in necrosis. However, CVC placement is not a benign procedure requiring a skilled clinician and the use of ultrasound guidance to prevent complications such as pneumothorax, bleeding or erroneous arterial cannulation. Furthermore, complications related to the maintenance of CVCs include deep vein thrombosis (DVT), and central line-associated blood stream infections (CLABSIs). These recognized complications occur in more than 15% of patients. There is a growing interest in peripheral vasopressor use for two main reasons: to expedite vasopressor administration in patients with refractory shock and to potentially avoid CVC placement and it complications. However, there remains no standardized protocols and many clinicians still believe that vasopressors must be infused through a CVC despite current evidence showing the safety of peripheral vasopressors. However, to date only observational studies have been performed. A randomized control trial is needed to provide high quality data to improve the future use of peripheral vasopressors, which has the potential to positively impact patient care.
The investigators will perform a feasibility study for the implementation of a peripheral vasopressor protocol. They will also assess the safety of the peripheral vasopressor protocol and evaluate clinically relevant outcomes, which will be listed below. The investigators hypothesize that implementing a peripheral vasopressor protocol is feasible and safe.
Aim 1: Adapt a peripheral vasopressor protocol and perform a feasibility study. The investigators will conduct a feasibility study to determine the efficacy of a peripheral vasopressor protocol. In collaboration with an ICU pharmacist, the investigators will adopt a peripheral vasopressor protocol at Kingston Health Sciences Center to determine the dosages and concentrations of each vasopressor. The participants will be randomized 1:1:1 into a low-dose peripheral vasopressor group vs. a dose peripheral vasopressor group vs a high-dose peripheral vasopressor group vs a CVC group. Based on the admission rates of our ICU, the investigators aim to recruit 25 patients into each group. They will investigate the feasibility of recruitment, data capture rate, acceptability rate by nursing staff and providers of the peripheral vasopressor protocol and avoidance rate of CVC placement.
Aim 2a: Perform a safety assessment of peripheral vasopressor protocol. The investigators will assess the safety of peripheral vasopressor administration after two months of protocol initiation. Specific adverse events to be captured include extravasation (+/- tissue necrosis), pneumothorax, arterial cannulation, and deep vein thrombosis. The investigators will assess any differences in adverse events between the low-dose peripheral vasopressor group vs the high-dose peripheral vasopressor group vs the CVC group, which will be reported as proportions. The investigators hypothesize that peripheral vasopressor use will be safe compared to the CVC group, with few to no adverse events.
Aim 2b: Determine the impact of a peripheral vasopressor protocol on clinically relevant outcomes. This feasibility study will investigate secondary outcomes such as alive and central line-free days, infection rates including CLABSIs, mortality and ICU/hospital length of stay. The investigators will report these outcomes as medians with 95% confidence intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study design is a prospective, pragmatic, unblinded feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Peripheral Venous Catheter | Experimental | Procedure: Experiemental: Peripheral Venous CatheterPatients 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. |
| Central Venous Catheter | Active comparator | Procedure: Experiemental: Peripheral Venous CatheterPatients in this group will have vasopressors infusing through a central venous catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experiemental: Peripheral Venous CatheterPatients 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. | Procedure or surgery | Central Venous Catheter, Peripheral Venous Catheter |
Primary outcome
The feasibility of recruitment
Time frame: 1 week
We hope to recruit at least 80% of patients who are eligible for the study.
Feasibility of data capture rate
Time frame: 1 week
We hope to have a data capture rate of at least 90%
Feasibility of acceptability rate of peripheral vasopressor protocol
Time frame: 1 week
We hope to have an acceptability rate of at least 90% by providers and nurses
6 secondary outcomes
Avoidance of central venous catheter placement
Time frame: 1 week
Assessing extravasation rates
Time frame: 1 week
Assessing alive and central line-free days
Time frame: 1 week
Assessing central-line associated blood stream infections
Time frame: 1 week
Assessing mortality rate
Time frame: 1 week
Assessing ICU and hospital length of stay
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 35605137Marti 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.
- Background: PubMed 25669592Loubani 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.
- Background: PubMed 37898185Munroe 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.
- Background: PubMed 12646670McGee 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.
- Background: PubMed 34600834Stolz 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.
- Background: PubMed 39078910Kalinoski 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.
- Background: PubMed 37536012Abu 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.
- Background: PubMed 33863361Owen 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.
- Background: PubMed 37611862Yerke 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.
- Individual participant dataSharing planned: Yes. Data that will be shared include age, sex, admission date and admitting diagnosis, peripheral IV location and gauge, vasopressor type, duration of vasopressor and complications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gord Dr., PhD, MD principal investigator
Queen's University, Kingston Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experiemental: Peripheral Venous Catheter in people with Shock and Peripheral Venous Catheterization, run by Kingston Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Boyd, PhD, MD (613-549-6666 ext. 6228, gordon.boyd@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of recruitment (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920173, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.