Back to resultsEarly Initiated Vasopressor Therapy in the Emergency Department (VASOSHOCK)
Primary Purpose
Shock, Shock, Septic, Hypotension
Status
Not yet recruiting
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Noradrenaline
Sponsored by
About this trial
This is an interventional treatment trial for Shock focused on measuring Peripherally infused noradrenaline, Fluid therapy, Fluid treatment, Non-hemorrhagic shock and hypotension, Emergency Department
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Signs or suspicion of hypotension or shock (Defined as SBP < 100mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L or by physician defined blood pressure for the individual patient combined with a lactate > 2.0 mmol/L). 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), see appendix 2, 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.
Sites / Locations
- Esbjerg Hospital
- Gødstrup Regional Hospital
- Zealand University Hospital
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
No ED administered noradrenaline. Standard care of hypotension and shock in the Danish ED's are fluid therapy and if not possible to achieve shock control, they are transferred to the ICU for administration of vasopressors if they are eligible for ICU admittance.
Outcomes
Primary Outcome Measures
Proportion of patients achieving either systolic blood pressure (SBP) >100 mmHg or mean arterial pressure (MAP) > 65 mmHg or a target blood pressure set by the treating physician at 90 minutes after inclusion
Bed-side assessment during treatment and registered in the case report form.
Secondary Outcome Measures
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.
Hours 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.
30-day all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
In-hospital mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05931601
Brief Title
Early Initiated Vasopressor Therapy in the Emergency Department
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Shock, Septic, Hypotension, Hypotension and Shock, Hypotension Symptomatic, Hypovolemia, Hypovolemic Shock, Hypovolemic
Keywords
Peripherally infused noradrenaline, Fluid therapy, Fluid treatment, Non-hemorrhagic shock and hypotension, Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No ED administered noradrenaline. Standard care of hypotension and shock in the Danish ED's are fluid therapy and if not possible to achieve shock control, they are transferred to the ICU for administration of vasopressors if they are eligible for ICU admittance.
Intervention Type
Drug
Intervention Name(s)
Noradrenaline
Other Intervention Name(s)
ATC-code C01CA03
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Proportion of patients achieving either systolic blood pressure (SBP) >100 mmHg or mean arterial pressure (MAP) > 65 mmHg or a target blood pressure set by the treating physician at 90 minutes after inclusion
Description
Bed-side assessment during treatment and registered in the case report form.
Time Frame
At 90 minutes
Secondary Outcome Measure Information:
Title
Number of intensive care unit (ICU) free days alive within 30 days
Description
Data is extracted from the Danish national registries or the patient's electronic medical record.
Time Frame
At 30 days
Title
Hours without shock within 24 hours
Description
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Time Frame
At 24 hours
Title
30-day all-cause mortality
Description
Data is extracted from the Danish national registries or the patient's electronic medical records.
Time Frame
At 30 days
Title
In-hospital mortality
Description
Data is extracted from the Danish national registries or the patient's electronic medical records.
Time Frame
At hospital discharge, an average of 30 days efter inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Signs or suspicion of hypotension or shock (Defined as SBP < 100mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L or by physician defined blood pressure for the individual patient combined with a lactate > 2.0 mmol/L).
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), see appendix 2, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lasse P Bentsen, MD
Phone
+4528555407
Email
lasse.paludan.bentsen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lasse P Bentsen, MD
Organizational Affiliation
Department of Emergency Medicine, Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mikkel Brabrand, MD, PhD
Organizational Affiliation
Department of Emergency Medicine, Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Esbjerg Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Biesenbach, MD
First Name & Middle Initial & Last Name & Degree
Peter Biesenbach, MD
Facility Name
Gødstrup Regional Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Larshan Perinpam, MD
First Name & Middle Initial & Last Name & Degree
Larshan Perinpam, MD
Facility Name
Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Tiwald, MD, DMSc
First Name & Middle Initial & Last Name & Degree
Gerhard Tiwald, MD, DMSc
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasse P Bentsen, MD
First Name & Middle Initial & Last Name & Degree
Lasse P Bentsen, MD
First Name & Middle Initial & Last Name & Degree
Mikkel Brabrand, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Early Initiated Vasopressor Therapy in the Emergency Department
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