Early Initiated Vasopressor Therapy in the Emergency Department

Phase 3

Recruiting

• Conditions: Shock; Hypovolemic Shock; Hypovolemic; Shock, Septic; Hypovolemia; Hypotension; Hypotension and Shock; Hypotension Symptomatic
• Interventions: Drug: Noradrenaline

• Registration Number: NCT05931601
• Lead Sponsor: Odense University Hospital

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 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.

Detailed Description

Please refer to the full protocol.

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-05
• Study Start: 2023-12-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Noradrenaline	Peripheral noradrenaline will be infused at rates of 0.05-0.15 mcg/kg/min for up to 24 hours after randomization in the ED until shock control is achieved. If shock control cannot be achieved, patients will be transferred to the ICU for further treatment of their condition but without further trial intervention. Weaning of intervention will be completed during the 24 hours, and if possible, terminated. If termination of treatment is not achievable within 24 hours, participants will be transferred to the ICU.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
30-day all-cause mortality	At 30 days	Data is extracted from the Danish national registries or the patient's electronic medical records.
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.
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.

Trial Locations

Locations (5)

Gødstrup Regional Hospital; 🇩🇰 Herning, Denmark

Esbjerg Hospital; 🇩🇰 Esbjerg, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Zealand University Hospital; 🇩🇰 Køge, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark