Safety of Norepinephrine Administered Through Peripheral Venous Catheter

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695445
• Other study ID #: EudraCT2018-002158-59
• Secondary ID: 2018-002158-59
• Status: Completed
• Start date: February 20, 2019
• Est. completion date: April 6, 2022

Study information

• Verified date: December 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: April 6, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Peripheral administration of Norepinephrine
Systematic follow-up of complications from peripheral administration of Norepinephrine

Locations

Country	Name	City	State
Sweden	Danderyds sjukhus	Stockholm	Danderyd
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Christer Svensen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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