Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Norepinephrine is a drug that elevates the blood pressure. It is routinely administered through peripheral catheters during surgery. There is a risk of tissue damage in case of leakage of Norepinephrine from the catheter to the surrounding tissue. Another risk is irregular administration of Norepinephrine due to kinking of the peripheral catheter. This could lead to fluctuations in blood pressure. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications. 1000 patients will be included. Inclusion criteria: Patients who will undergo surgery with need for vasopressor support. Exclusion criteria: The patient has a central venous catheter, a peripherally inserted central venous catheter or lack of informed consent.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyds sjukhus, Stockholm, Danderyd, Sweden

About this study

In many hospitals in Sweden, Norepinephrine is administered through peripheral venous catheters in the operating room. However there are very few studies to support the safety of peripherally administered Norepinephrine.

Norepinephrine of the concentration 8 respectively 40 microg/ml will be investigated. The primary aim of the study is to investigate complications from Norepinephrine administered in peripheral venous catheters. The secondary aim is to investigate if comorbidity, placement of the peripheral catheter or the duration of the infusion are associated with a higher rate of complications.

The localisation and size of the peripheral venous catheter will be registered. The blood pressure will me measured every 5 minutes and every minute in case of systolic blood pressure over 220 mm Hg.

The site of administration will regularly be monitored for complications. If subcutaneous infusion of Norepinephrine is suspected, the patient will be followed up for up to 48 hours or until hospital discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient who has general anesthesia or central blocks
Need for vasopressors in the pre, per or postoperative period to maintain adequate mean arterial blood pressure
Age ≥18 years

Exclusion criteria

The patient has a central venous line
The patient has a peripherally inserted central line
Lack of informed consent

Treatment and study plan

Peripheral administration of Norepinephrine

Drug

Systematic follow-up of complications from peripheral administration of Norepinephrine

Primary outcomes

Proportion of patients with treatment-related adverse events

Time frame: 0-72 hours

Proportion of patients with complications (Subcutaneous infusion and/or hypertension>220 mmHg and/or heart rate<40 beats/min)

Secondary outcomes

Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications

Time frame: 0-72 hours

Odds ratio of Treatment-Emergent Adverse Events in risk groups (ASA>2, placement of catheter distal to the antecubital or popliteal fossae, duration of infusion> 4 hours)

Sponsors and collaborators

Lead sponsor

Christer Svensen

Other

Registry information

Official study title

A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Oct 4, 2018
Registry last updated: Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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