Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Completed

• Conditions: Hypotension
• Interventions: Drug: Peripheral administration of Norepinephrine

• Registration Number: NCT03695445
• Lead Sponsor: Christer Svensen

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2019-02-20
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral Norepinephrine	Peripheral administration of Norepinephrine	Patients who will undergo surgery with need for vasopressor support.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications	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)

Trial Locations

Locations (3)

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Danderyd, Sweden

Karolinska Universitetssjukhuset; 🇸🇪 Stockholm, Sweden