Safety of Norepinephrine Administered Through Peripheral Venous Catheter

NCT03695445 | Completed FDA Drug

• 2 other identifiers: EudraCT2018-002158-592018-002158-59
• Study Type: observational
• Target: 1,004
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications

  0-72 hours

Study Arms (1)

Peripheral Norepinephrine

Patients who will undergo surgery with need for vasopressor support.

Drug: Peripheral administration of Norepinephrine

Interventions

Peripheral administration of Norepinephrine DRUG

Systematic follow-up of complications from peripheral administration of Norepinephrine

Peripheral Norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• The patient has a central venous line
• The patient has a peripherally inserted central line
• Lack of informed consent

Sponsors & Collaborators

• Christer Svensen: lead

Study Sites (3)

Danderyds sjukhus

Stockholm, Danderyd, 182 88, Sweden

Location

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elisabeth Andersson, MD

  Stockholm South General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 4, 2018
• Study Start: February 20, 2019
• Primary Completion: April 4, 2022
• Study Completion: April 6, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)