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A prospective study of the safety of peripherally administered norepinephrine during surgery

A prospective study of the safety of peripherally administered norepinephrine during surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2018-002158-59-SE
Enrollment
1000
Registered
2018-07-05
Start date
2018-09-05
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension during general anaesthesia or central blockades

Interventions

Trade Name: Noradrenalin Abcur, Noradrenalin Hospira Pharmaceutical Form: Concentrate for solution for infusion

Sponsors

Södersjukhuset
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 years or above who undergo general anaesthesia or central blockades in the operation theater with hypotension and need of vasopressor support can be included. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500

Exclusion criteria

Exclusion criteria: Lack of consent. The patient has a central venous catheter in place.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study side effects of peripheral administration of norepinephrine. ;Secondary Objective: Secondary objective is to study if the localisation of the peripheral venous catheter, the duration of the infusion or comorbidity are associated with higher complication rate. ;Primary end point(s): Percentage of adverse events and serious adverse events. We will study inadverent subcutaneous infusion, white colouring of the skin and hypertension (systolic blood pressure>220 mmHg) and skin necrosis;Timepoint(s) of evaluation of this end point: During the study period, maximum length 72 hours.

Secondary

MeasureTime frame
Secondary end point(s): Secondary aims are to evaluate if comorbidity, the localisation of the peripheral venous catheter or the duration of infusion is associated with higher incidence of complications. ;Timepoint(s) of evaluation of this end point: During the study period, maximum 72hours.

Countries

Sweden

Contacts

Public ContactMaria Cronhjort

Södersjukhuset

maria.cronhjort@sll.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026