Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
500
Countries
1
Sites
23
Septic Shock
To test if a CRT-targeted resuscitation based on clinical hemodynamic phenotyping can improve a hierarchical clinical outcome - mortality, time to cessation of vital support, and length of hospital stay, all within 28 days - in septic shock patients as compared to usual care.
Key facts
- Sponsor
- Pontificia Universidad Catolica de Chile
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 27 May 2022 → 28 Jul 2025
- Decision date (initial)
- 2025-01-23
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519691-10-00
- EudraCT number
- 2021-005358-28
- ClinicalTrials.gov
- NCT05057611
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To test if a CRT-targeted resuscitation based on clinical hemodynamic phenotyping can improve a hierarchical clinical outcome - mortality, time to cessation of vital support, and length of hospital stay, all within 28 days - in septic shock patients as compared to usual care.
Conditions and MedDRA coding
Septic Shock
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10040070 | Septic shock | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Consecutive adult patients (≥ 18 years) with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h.
Exclusion criteria 1
- More than 4 hours since septic shock diagnosis - Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period - Active bleeding, - Do not resuscitate status, - Child B-C Cirrhosis - Underlying disease process with a life expectancy < 90 days and/or the attending clinician deems aggressive resuscitation unsuitable - Refractory shock (high risk of death within 24h) - Pregnancy - Concomitant severe acute respiratory distress syndrome. - Patients in whom CRT cannot be accurately assessed.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is a hierarchical composite of all cause mortality within 28 days, time to cessation of vital support (truncated at 28 days) and length of hospital stay (truncated at 28 days).
Secondary endpoints 1
- All-cause mortality within 28 days (Time Frame: 28days)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Suero Fisiológico Vitulia 0,9 % solución para perfusión
PRD11709352 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3000 ml millilitre(s)
- Max total dose
- 3000 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB — SOLUTIONS AFFECTING THE ELECTROLYTE BALANCE
- Marketing authorisation
- 41.671
- MA holder
- LABORATORIOS ERN, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lactato Ringer Braun, solução para perfusão
PRD5409993 · Product
- Active substance
- Potassium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 3000 ml millilitre(s)
- Max total dose
- 3000 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 3604584
- MA holder
- B. BRAUN MEDICAL LDA.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pontificia Universidad Catolica de Chile
- Sponsor organisation
- Pontificia Universidad Catolica de Chile
- Address
- Avenida Libertador Bernardo O'Higgins 340
- City
- Santiago
- Postcode
- 8331150
- Country
- Chile
Scientific contact point
- Organisation
- Pontificia Universidad Catolica de Chile
- Contact name
- Karla Ramos
Public contact point
- Organisation
- Pontificia Universidad Catolica de Chile
- Contact name
- Karla Ramos
Locations
1 EU/EEA country · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 500 | 23 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario De La Princesa
Anestesiología y Reanimación, Calle De Diego De Leon 62, 28006, Madrid
Hospital General Universitario Gregorio Maranon
Anestesiología y Reanimación, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Y Politecnico La Fe
Anestesiología y Reanimación, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Anestesiología y Reanimación, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario De Leon
Anestesiología y Reanimación, Calle Altos De Nava S/n, 24071, Leon
Hospital Universitario De Cruces
Anestesiología y Reanimación, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Nuestra Senora De Candelaria
Servicio de Anestesiología y Reanimación., Carretera De Rosario 145, Resto, Santa Cruz De Tenerife
Clinica Universidad De Navarra
Anestesiología y Reanimación, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital General Universitario De Valencia
Anestesiología y Reanimación, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital General Universitario De Elche
Anestesiología y Reanimación, Edificio 2, Camino De La Almazara 11, Elche
Hospital Clinico Universitario De Valencia
Anestesiología y Reanimación, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Rio Hortega
Anestesiología y Reanimación, Calle Dulzaina 2, 47012, Valladolid
Hospital General Universitario De Ciudad Real
ervicio de Anestiología y Reanimación, Calle Del Obispo Rafael Torija S/n, 13005, Ciudad Real
Hospital Del Mar
Anestesiología y Reanimación, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Clinic De Barcelona
Medicina intensiva, Calle Villarroel 170, 08036, Barcelona
Complejo Hospitalario Universitario De Ourense
Anestesiología y Reanimación, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario Central De Asturias
Anestesiología y Reanimación, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario De Mostoles
Anestesiología y Reanimación, Calle Rio Jucar S/N, 28935, Mostoles
Hospital Alvaro Cunqueiro
Anestesiología y Reanimación, Estrada Clara Campoamor No 341, 36312, Vigo
Hospital Universitario Ramon Y Cajal
Anestesiología y Reanimación, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Povisa S.A.
Anestesiología y Reanimación, Rua Salamanca 5, 36211, Vigo
Hospital Universitari Vall D Hebron
Servicio de Anestesiología y Reanimación. Hospital Vall d’Hebron, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario San Juan De Alicante
Anestesiología y Reanimación, Carretera N-332 Alicante-Valencia S/n, 03550, Sant Joan D'alacant
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2022-05-27 | 2025-07-28 | 2022-06-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocolo Andromeda 2_adaptSpain_V7_25042023 | 7 |
| Recruitment arrangements (for publication) | 0_Transition template | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mayor 18_version 4_20230425 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Lactato Ringer_ ANDROMEDA-SHOCK-2 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Suero Fisiologico_ANDROMEDA-SHOCK-2 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-30 | Spain | Acceptable with conditions 2025-01-22
|
2025-01-23 |