Shock, Shock, Septic, Hypotension, Hypotension and Shock, Hypotension Symptomatic, Hypovolemia, Hypovolemic Shock, Hypovolemic
Conditions
Keywords
Peripherally infused noradrenaline, Fluid therapy, Fluid treatment, Non-hemorrhagic shock and hypotension, Emergency Department
Brief summary
The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish and Swedish Emergency Departments (ED). The main questions it aims to answer are: If early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can * Improve time to shock control. * Reduce the need for ICU admittance. * Decrease mortality. Participants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay. After completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers. Patients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves. Researchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish and Swedish Emergency Departments.
Detailed description
Please refer to the full protocol.
Interventions
DRUGNoradrenaline
See arm description
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the
Exclusion criteria
) defined as: 1. SBP \< 100mmHg or MAP \< 65 mmHg combined with lactate \> 2.0 mmol/L, 2. Physician defined blood pressure for the individual patient combined with a lactate \> 2.0 mmol/L 3. Either SBP \< 100mmHg or MAP \< 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician. * Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival. * Clinical Frailty Score (CFS) of ≤4. If CFS is ≥5 and the treating physician find the patient suitable for ICU admittance, the participant can be enrolled, if the on-call ICU doctor would accept the patient for ICU admittance. If the treating physician is unsure of ICU eligibility, regardless of CFS score, the patient should be consulted with the ICU consultant before study inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion. | At 90 minutes | Bed-side assessment during treatment and registered in the case report form. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intensive care unit (ICU) free days alive within 30 days | At 30 days | Data is extracted from the Danish national registries or the patient's electronic medical record. Note: Death will count as 0 days. |
| Time without shock within 24 hours | At 24 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| 30-day all-cause mortality | At 30 days | Data is extracted from the Danish national registries or the patient's electronic medical records. |
| In-hospital all-cause mortality | At hospital discharge, an average of 30 days efter inclusion | Data is extracted from the Danish national registries or the patient's electronic medical records. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of organ support free days alive within 30 days | At 30 days | Organ support is defined as either mechanical ventilation, vasopressor/inotrope therapy or dialsysis. Data is extracted from the Danish national registries or the patient's electronic medical record. |
| Proportion of patients admitted to the ICU | At 30 days | Data is extracted from the patient's electronic medical records. |
| ED Length of stay | At 72 hours | Data is extracted from the patient's electronic medical records. |
| ICU length of stay | At 30 days | Data is extracted from the patient's electronic medical records. |
| Proportion of patients receiving vasopressor at any point within 24 hours | At 24 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| Proportion and duration of mechanical ventilation | At 30 days | Data is extracted from the patient's electronic medical records. |
| Proportion and length of renal replacement therapy | At 30 days | Data is extracted from the patient's electronic medical records. |
| Amount of fluid therapy within the first 24 hours | At 24 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| Proportion of serious adverse events for noradrenaline or fluid therapy, e.g. extravasation or overdosis of noradrenaline, pulmonary edema, new cardiac arrhytmias, during the intervention of control period | At 24 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| Hospital length of stay | At 30 days | Data is extracted from the patient's electronic medical records. |
| Time to vasopressor initiation | At 30 days | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| Hours of vasopressor infusion | At 30 days | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| Proportion of patients with pulmonary oedema within 72 hours | At 72 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
| Proportion of patients with acute kidney failure within 72 hours | At 72 hours | Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record. |
Countries
Denmark, Sweden
Contacts
Primary ContactLasse P Bentsen, MD
Outcome results
None listed