Early Initiated Vasopressor Therapy in the Emergency Department - A Multi-center Randomized Controlled Trial (VASOSHOCK)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

8 Dec 2023 → ongoing

Decision date (initial)

2023-09-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

The PhD fund of the Region of Southern Denmark · The Medicine Fund of The Danish Regions · The Region of Southern Denmark and Region Zealands Research Fund

External identifiers

EU CT number

2023-504584-16-00

ClinicalTrials.gov

NCT05931601

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

The aim is to investigate whether the use of early initiated vasopressor therapy (i.e., noradrenaline) compared to fluid therapy alone in non-bleeding hypotensive patients presenting in the ED can improve time to shock control and by that, reduce the need for ICU admittance.

Conditions and MedDRA coding

Hypotension

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. At least 18 years of age
2. Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as: a. SBP < 100mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L, b. Physician defined blood pressure for the individual patient combined with a lactate > 2.0 mmol/L c. 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.
3. Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration)
4. 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 6

1. Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician.
2. Known or suspected pregnancy
3. 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.
4. Known allergy to noradrenaline.
5. Severe organ failure outside circulatory failure that requires immediate ICU admission.
6. Previously enrolled in the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 4

1. Number of ICU free days alive within 30 days
2. Time without shock within 24 hours
3. 30-day all-cause mortality.
4. In-hospital all-cause mortality

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Mikkel Brabrand, Sponsor.

Public contact point

Organisation

Odense University Hospital

Contact name

Lasse Paludan Bentsen, Coordinating and Principal Investigator

Third parties 1

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications