A prospective study of the safety of peripherally administered norepinephrine during surgery
Phase 1
- Conditions
- Hypotension during general anaesthesia or central blockadesTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2018-002158-59-SE
- Lead Sponsor
- Södersjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 1000
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
Lack of consent. The patient has a central venous catheter in place.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.