Safety of Norepinephrine Administered Through Peripheral Venous Catheter

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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Drug: Peripheral administration of Norepinephrine

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1004

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 118 83
    • Södersjukhuset
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset
  • Danderyd
    • Stockholm, Danderyd, Sweden, 182 88
      • Danderyds Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who require vasopressors to maintain an adequate blood pressure during general anesthesia and/or central blocks.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peripheral Norepinephrine; Patients who will undergo surgery with need for vasopressor support.	Drug: Peripheral administration of Norepinephrine; Systematic follow-up of complications from peripheral administration of Norepinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with treatment-related adverse events	Proportion of patients with complications (Subcutaneous infusion and/or hypertension>220 mmHg and/or heart rate<40 beats/min)	0-72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications	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)	0-72 hours

Collaborators and Investigators

• Sponsor: Christer Svensen
• Investigators: Principal Investigator: Elisabeth Andersson, MD, Stockholm South General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine
• Other Study ID Numbers: EudraCT2018-002158-59; 2018-002158-59 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No