Clinical trial NCT03695445: Safety of Norepinephrine Administered Through Peripheral Venous Catheter
Official title: A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who require vasopressors to maintain an adequate blood pressure during general anesthesia and/or central blocks.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with treatment-related adverse events
timeFrame: 0-72 hours
Secondary outcomes:
measure: Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
state: Danderyd
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
Study officials:
affiliation: Stockholm South General Hospital
name: Elisabeth Andersson, MD
role: PRINCIPAL_INVESTIGATOR
References: