Early Initiated Vasopressor Therapy in the Emergency Department

Hypotension Clinical Trial

— VASOSHOCK  

Official title:

Early Initiated Vasopressor Therapy vs. Standard Care of Primarily Fluid Therapy in Hypotensive Patients in the Emergency Department - A Pragmatic, Multi-center, Superiority, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931601
• Other study ID #: OP_1749
• Secondary ID: 2023-504584-16-0
• Status: Recruiting
• Phase: Phase 3
• Start date: December 8, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: June 2024
• Source: Odense University Hospital
• Contact: Lasse P Bentsen, MD
• Phone: +4520496950
• Email: lasse.paludan.bentsen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 Emergency Departments.

Description:

Please refer to the full protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.

• Fertile women (<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding.

• Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant.

• Known allergy to noradrenaline.

Related Conditions & MeSH terms

• Emergencies
• Hypotension
• Hypotension and Shock
• Hypotension Symptomatic
• Hypovolemia
• Hypovolemic
• Hypovolemic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Noradrenaline
See arm description

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Esbjerg Hospital	Esbjerg
Denmark	Gødstrup Regional Hospital	Herning
Denmark	Zealand University Hospital	Køge
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients receiving vasopressor at any point within 24 hours	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 24 hours
Other	Time to vasopressor initiation	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 30 days
Other	Hours of vasopressor infusion	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 30 days
Other	Proportion of patients with pulmonary oedema within 72 hours	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 72 hours
Other	Proportion of patients with acute kidney failure within 72 hours	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 72 hours
Other	Proportion of patients admitted to the ICU	Data is extracted from the patient's electronic medical records.	At 30 days
Other	ED Length of stay	Data is extracted from the patient's electronic medical records.	At 72 hours
Other	ICU length of stay	Data is extracted from the patient's electronic medical records.	At 30 days
Other	Hospital length of stay	Data is extracted from the patient's electronic medical records.	At 30 days
Other	Proportion and duration of mechanical ventilation	Data is extracted from the patient's electronic medical records.	At 30 days
Other	Proportion and length of renal replacement therapy	Data is extracted from the patient's electronic medical records.	At 30 days
Other	Amount of fluid therapy within the first 24 hours	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 24 hours
Other	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	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 24 hours
Primary	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.	Bed-side assessment during treatment and registered in the case report form.	At 90 minutes
Secondary	Number of intensive care unit (ICU) free days alive within 30 days	Data is extracted from the Danish national registries or the patient's electronic medical record.	At 30 days
Secondary	Time without shock within 24 hours	Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.	At 24 hours
Secondary	30-day all-cause mortality	Data is extracted from the Danish national registries or the patient's electronic medical records.	At 30 days
Secondary	In-hospital all-cause mortality	Data is extracted from the Danish national registries or the patient's electronic medical records.	At hospital discharge, an average of 30 days efter inclusion