HypotensionNCT03695445
Safety of Norepinephrine Administered Through Peripheral Venous Catheter
An observational study of Hypotension, run by Christer Svensen at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Peripheral administration of Norepinephrine
- How many people
- 1,004 participants
- Where
- 3 sitesSweden
- Study dates
- 20 Feb 2019to 6 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who require vasopressors to maintain an adequate blood pressure during general anesthesia and/or central blocks.
Who may be able to join
- 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
Who cannot join
- The patient has a central venous line
- The patient has a peripherally inserted central line
- Lack of informed consent
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Danderyds sjukhus
Stockholm, Danderyd, 182 88
Södersjukhuset
Stockholm, 118 83
Karolinska Universitetssjukhuset
Stockholm
About this study
Official title: A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery
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.
Read the 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.
- Conditions
- Hypotension
- Being tested
- Peripheral administration of Norepinephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral administration of NorepinephrineDrug
Systematic follow-up of complications from peripheral administration of Norepinephrine
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Norepinephrine | Patients who will undergo surgery with need for vasopressor support. Receives: Drug: Peripheral administration of Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0-72 hours
Secondary outcomes (1)
Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications
Odds ratio of Treatment-Emergent Adverse Events in risk groups (ASA>2, placement of catheter distal to the antecubital or popliteal fossae, duration of infusion> 4 hours)
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start20 Feb 2019
- Primary completion4 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christer Svensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Elisabeth Andersson, MD, Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695445
- Sponsor's protocol ID
- EudraCT2018-002158-59
- Other IDs
- 2018-002158-59, 2018
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2018
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Safety of Norepinephrine Administered Through Peripheral Venous Catheter During Surgery
- ClinicalTrials.gov ID
- NCT03695445
- Acronym / sponsor ID
- EudraCT2018-002158-59
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Christer SvensenUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Norepinephrine | – | Drug: Peripheral administration of NorepinephrinePatients who will undergo surgery with need for vasopressor support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who require vasopressors to maintain an adequate blood pressure during general anesthesia and/or central blocks.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- The patient has a central venous line
- The patient has a peripherally inserted central line
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral administration of NorepinephrineSystematic follow-up of complications from peripheral administration of Norepinephrine | Drug | Peripheral Norepinephrine |
Primary outcome
Proportion of patients with treatment-related adverse events
Time frame: 0-72 hours
Proportion of patients with complications (Subcutaneous infusion and/or hypertension>220 mmHg and/or heart rate<40 beats/min)
1 secondary outcome
Association between comorbidity, placement of catheter, duration of infusion and increased proportion of complications
Time frame: 0-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Andersson, MD principal investigator
Stockholm South General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by Christer Svensen at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with treatment-related adverse events (time frame: 0-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.