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Safety of Norepinephrine Administered Through Peripheral Venous Catheter

NCT ID: NCT03695445

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-20

Study Completion Date

2022-04-06

Brief Summary

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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

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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

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Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Peripheral Norepinephrine

Patients who will undergo surgery with need for vasopressor support.

Peripheral administration of Norepinephrine

Intervention Type DRUG

Systematic follow-up of complications from peripheral administration of Norepinephrine

Interventions

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Peripheral administration of Norepinephrine

Systematic follow-up of complications from peripheral administration of Norepinephrine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christer Svensen

OTHER

Sponsor Role lead

Responsible Party

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Christer Svensen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Elisabeth Andersson, MD

Role: PRINCIPAL_INVESTIGATOR

Stockholm South General Hospital

Locations

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Danderyds sjukhus

Stockholm, Danderyd, Sweden

Site Status

Södersjukhuset

Stockholm, , Sweden

Site Status

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2018-002158-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EudraCT2018-002158-59

Identifier Type: -

Identifier Source: org_study_id