Norepinephrine administration timing
| ISRCTN | ISRCTN13420347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13420347 |
| Sponsors | Region Stockholm, Karolinska Institutet |
| Funder | The ALF Agreement (Regional Agreement on Medical Training and Clinical Research) between the Swedish Government and Karolinska Institutet |
- Submission date
- 21/01/2026
- Registration date
- 03/02/2026
- Last edited
- 03/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Sepsis is a life-threatening condition. Current clinical guidelines recommend norepinephrine (NE) as the primary treatment to increase blood pressure. However, it remains unclear exactly when this treatment should be initiated. Delayed treatment may lead to patients receiving excessive amounts of intravenous fluids, which can be harmful.
This study examines how quickly patients with sepsis receive NE in Sweden and the volume of fluids administered. We are studying patients at the emergency departments of four different hospitals. The goal is to determine if there is a correlation between the time to NE treatment and the amount of fluid given. The hypothesis is that patients who receive NE later also receive a larger volume of fluids.
Who can participate?
Patients who present to the emergency department in Swedish hospitals aged ≥ 18 years with suspected sepsis, defined as blood cultures obtained and intravenous antibiotics administered, and hypotension, defined as MAP < 65 mmHg.
What does the study involve?
This is an observational study. Participants are identified at the Emergency Department (ED) based on clinical criteria (suspected sepsis and hypotension). Data is collected prospectively using a paper Case Report Form (CRF) and supplemented with data from the participants' electronic medical records (EMR). Participation involves no changes to standard clinical care; the study only monitors and records the timing of interventions and fluid volumes as they occur in real-time or as documented in the medical records during the first 24 hours of care.
What are the possible benefits and risks of participating?
The results may indicate whether there is a need to adjust current clinical routines regarding the timing of sepsis treatment. This, in turn, could lead to improved patient care and a reduced risk of complications. The study does not affect the patients' treatment directly; instead, it gathers essential knowledge to improve healthcare in the future.
Where is the study run from?
Region Stockholm and the Karolinska Institute, Sweden.
When is the study starting and how long is it expected to run for?
February 2026 to December 2026.
Who is funding the study?
The ALF Agreement (Regional Agreement on Medical Training and Clinical Research) between the Swedish Government and Karolinska Institute, Sweden.
Who is the main contact?
Dr Maria Cronhjort, maria.cronhjort@regionstockholm.se
Contact information
Scientific, Principal investigator
Entrevägen 2
Stockholm
18288
Sweden
| Phone | +460812355000 |
|---|---|
| maria.cronhjort@regionstockholm.se |
Public
Entrevägen 2
Stockholm
18288
Sweden
| Phone | +460812355000 |
|---|---|
| mikael.hallengren@regionstockholm.se |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Participant information sheet | 48878_PIS poster.pdf |
| Scientific title | Time to norepinephrine in sepsis – a prospective inception cohort study |
| Study acronym | NEAT |
| Study objectives | Rationale If norepinephrine (NE) initiation is delayed and excessive fluids are administered during this period, it could necessitate a change in current Swedish clinical practice. This study aims to provide data on the time to NE initiation and fluid administration in adult patients with sepsis and hypotension in Sweden. Objectives 1. To describe the use of NE in patients with sepsis in Swedish hospitals. 2. To describe the volume and type of fluids administered during the first 24 hours in Swedish hospitals. 3. Explore the association between amounts of fluids and the timing of NE initiation. |
| Ethics approval(s) |
Approved 02/06/2025, Swedish Ethical Review Authority (Box 2110, Uppsala, 75002, Sweden; +46 0104750800; registrator@etikprovning.se), ref: 2025-03002-01 |
| Health condition(s) or problem(s) studied | Sepsis with hypotension |
| Intervention | This is an observational study. Participants are identified at the Emergency Department (ED) based on clinical criteria (suspected sepsis and hypotension). Data is collected prospectively using a paper Case Report Form (CRF) and supplemented with data from the participants' electronic medical records (EMR). Participation involves no changes to standard clinical care; the study only monitors and records the timing of interventions and fluid volumes as they occur in real-time or as documented in the medical records during the first 24 hours of care. Study design and setting This is a prospective, multicenter cohort study involving emergency departments across Sweden. Patients will be enrolled over 28 days. Number of subjects The study aims to include approximately 204 patients who present to the emergency department in Swedish hospitals with sepsis and hypotension and where at least 61 subsequently receive NE. Expected duration of the study Each participating site will select 28 days for patient enrollment. Follow-up will continue for 90 days post-enrollment. The study is anticipated to commence on [Start Date] and conclude on [End Date]. Participants All patients presenting to the emergency department at each site with suspected sepsis and hypotension will be screened for eligibility by local investigators. Discontinuation of data collection Data collection will go on for 24 hours. Study closure The study will end after the pre-planned number of participants has been enrolled. |
| Intervention type | Not Specified |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 61 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Suspected sepsis defined as, blood cultures obtained and intravenous antibiotics administered. 3. Hypotension defined as MAP < 65 mmHg. 4. eSOFA 2 points or more |
| Key exclusion criteria | Prior enrollment in this study. |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Stockholm
18288
Sweden
Stockholm
11883
Sweden
Stockholm
11219
Sweden
Skövde
54949
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 03/02/2026 | No | Yes | ||
| Protocol file | 22/01/2026 | No | No | ||
| Statistical Analysis Plan | 22/01/2026 | No | No |
Additional files
- 48878_SAP.pdf
- Statistical Analysis Plan
- 48878_Protocol.pdf
- Protocol file
- 48878_PIS poster.pdf
- Participant information sheet
Editorial Notes
03/02/2026: Study’s existence confirmed by the Swedish Ethical Review Authority, Sweden.
