Clinical trial • Phase III • Cardiology

NORADRENALINE TARTRATE for Critical illness

Phase III trial of NORADRENALINE TARTRATE for Critical illness. Randomised. 320 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Critical illness
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-02-2023
First CTIS Authorization Date
06-03-2024

Trial design

Randomised Phase III trial across 19 sites in Italy, Ireland.

Randomised
Yes
Target Sample Size
320

Eligibility

Recruits 320 Vulnerable population selected. The trial includes critically ill adults (isVulnerablePopulationSelected = true). Subject information and informed consent forms and multiple documents titled 'Assent to continue and Information' and 'PIL and CONSENT to Continue' are present (see listed documents), indicating procedures for consent/assent for participants who may lack capacity..

Pregnancy Exclusion
Pregnant or suspected pregnancy
Vulnerable Population
Vulnerable population selected. The trial includes critically ill adults (isVulnerablePopulationSelected = true). Subject information and informed consent forms and multiple documents titled 'Assent to continue and Information' and 'PIL and CONSENT to Continue' are present (see listed documents), indicating procedures for consent/assent for participants who may lack capacity.

Inclusion criteria

  • {"criterion_text":"- Planned procedure is in-hospital urgent tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit\n- Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment)\n- Administration of sedation (with or without neuromuscular blockade) is planned\n- Age 18 years or older"}

Exclusion criteria

  • {"criterion_text":"- No vasopressors/inotropes at the moment of screening for eligibility\n- MAP < 60 mmHg or > 120 mmHg at the moment of screening for eligibility\n- Urgency of intubation precludes safe performance of study procedures\n- Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest\n- Enrolled in another clinical trial that is unapproved for co-enrolment\n- Pregnant or suspected pregnancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Mean arterial pressure (MAP) < 60 mmHg\n- Cardiac arrest","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Cardiac arrest within 30 minutes from induction\n- Mean arterial pressure (MAP) < 60 mmHg\n- Lowest systolic blood pressure within 30 minutes from induction\n- Need for a rescue vasopressor\n- Change in systolic blood pressure from last value before induction to lowest value up to 30 minutes from induction\n- Severe hypertension (MAP > 120 mmHg) by 30 minutes from induction","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
320
Recruitment Window Months
24
Consent Approach
Subject information and informed consent forms for adults are provided (documents labelled 'L1_ SIS and ICF Adults' and similar). Documents titled 'PREVENTION Assent to continue and Information' and 'PIL and CONSENT to Continue' are present, indicating use of consent and assent/consent-to-continue procedures for participants who may lack capacity. Specific who provides consent, age-specific documents languages or full consent procedures are not detailed in the available record.

Geography

Total Number Of Sites
19
Total Number Of Participants
320

Italy

Earliest CTIS Part Ii Submission Date
23-02-2023
Latest Decision Or Authorization Date
20-05-2025
Processing Time Days
817
Number Of Sites
15
Number Of Participants
300

Sites

Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
Biologia Cellulare, Computazionale e Integrata
Contact Person Name
Silvia De Rosa
Contact Person Email
ospedale.trento@pec.apss.tn.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Anestesia e Rianimazione
Contact Person Name
Vincenzo Russotto
Contact Person Email
vincenzo.russotto@unito.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
Emergenza
Contact Person Name
Tiziana Bove
Contact Person Email
tiziana.bove@uniud.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Anestesia, Rianimazione ed Emergenza
Contact Person Name
Marinella Zanierato
Contact Person Email
marinella.zanierato@unito.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
UOC Anestesia e Rianimazione
Contact Person Name
Jonathan Montomoli
Site Name
Humanitas Research Hospital
Department Name
Biomedical Sciences
Contact Person Name
Alessandro Protti
Contact Person Email
alessandro.protti@hunimed.eu
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Emergenza e Urgenza
Contact Person Name
Emanuele Rezoagli
Contact Person Email
emanuele.rezoagli@unimib.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Dipartimento: SCIENZE CHIRURGICHE, ODONTOSTOMATOLOGICHE E MATERNO-INFANTILI
Contact Person Name
Katia Donadello
Contact Person Email
katia.donadello@univr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze dell’emergenza, anestesiologiche e della rianimazione
Contact Person Name
Gennaro De Pascale
Site Name
Universita' Degli Studi Di Ferrara
Department Name
Medicina traslazionale
Contact Person Name
Savino Spadaro
Contact Person Email
spdsvn@unife.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Anestesia e Rianimazione
Contact Person Name
Chiara Robba
Contact Person Email
kiarobba@gmail.com
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Anestesia e Rianimazione 1
Contact Person Name
Thomas Langer
Contact Person Email
thomas.langer@unimib.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Anestesia, Terapia Intensiva e Emergenza
Contact Person Name
Giacomo Grasselli
Contact Person Email
giacomo.grasselli@unimi.it
Site Name
A.O.SS Antonio Biagio e Cesare Arrigo Alessandria
Department Name
Dept. of Anaesthesia and Intensive Care Medicine
Contact Person Name
Gianmaria Cammarota
Contact Person Email
fravazzoni@ospedale.al.it
Site Name
ASST Ovest Milanese - Ospedale Vecchio di Legnano
Department Name
Dept. of Anaesthesia and Intensive Care Medicine
Contact Person Name
Giovanni Mistraletti

Ireland

Earliest CTIS Part Ii Submission Date
24-02-2025
Latest Decision Or Authorization Date
04-09-2025
Processing Time Days
192
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Beaumont Hospital
Department Name
Dept. of Anaesthesia and Intensive Care Medicine
Contact Person Name
Ger Curley
Contact Person Email
gercurley@rcsi.ie
Site Name
Tallaght University Hospital, Dublin
Department Name
Dept. of Anaesthesia and Intensive Care Medicine
Contact Person Name
Yvelynne Kelly
Contact Person Email
yvkelly@tcd.ie
Site Name
The Mater University Hospital
Department Name
Dept. of Anaesthesia and Intensive Care Medicine
Contact Person Name
Aisling McMahon
Contact Person Email
aislingmcmahon@mater.ie
Site Name
Galway University Hospital
Department Name
Dept. of Anaesthesia and Intensive Care Medicine
Contact Person Name
Bairbre McNicholas

Sponsor

Primary sponsor

Full Name
Universita Degli Studi Di Torino
Organisation Type
Educational Institution
Country Of Registered Address
Italy

Co-sponsors

  • Mario Negri Institute For Pharmacological Research IRCCS

Investigational products

Investigational Product Name
NORADRENALINA TARTRATO MONICO 2 mg/ml Concentrato per soluzione per infusione
Active Substance
NORADRENALINE TARTRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Marketing authorisation present (marketingAuthNumber: 030799011, authorisationCountryCode: IT)
Maximum Dose
maxDailyDoseAmount 1 mg/kg; maxTotalDoseAmount 10 (mg/kg)

Related trials

Other published trials that may interest you.