NCT03695445

Safety of Norepinephrine Administered Through Peripheral Venous Catheter

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,004 (actual)
• Sponsor: Christer Svensen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension

Interventions

Type	Name	Description
DRUG	Peripheral administration of Norepinephrine	Systematic follow-up of complications from peripheral administration of Norepinephrine

Timeline

• Start date: 2019-02-20
• Primary completion: 2022-04-04
• Completion: 2022-04-06
• First posted: 2018-10-04
• Last updated: 2022-12-09

Locations

3 sites across 1 country: Sweden

Regulatory

• FDA-regulated drug study