Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
1
Non-toxic acute cardiogenic shock
The main objective is to assess the efficacy and safety of HIET in non-toxic cardiogenic shock using invasive hemodynamic monitoring, Hence to investigate the hemodynamic effects and safety of the potentially new inotropic and cardiovascular stabilizing agent as treatment in NTCS.
Key facts
- Sponsor
- Oslo Universitetssykehus HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09], Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-07-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Oslo University Hospital, Department of Cardiology, Research Grant
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
The main objective is to assess the efficacy and safety of HIET in non-toxic cardiogenic shock using invasive hemodynamic monitoring, Hence to investigate the hemodynamic effects and safety of the potentially new inotropic and cardiovascular stabilizing agent as treatment in NTCS.
Secondary objectives 1
- The secondary objective results will inform the need for a larger trial designed to affect the intervention on clinical events.
Conditions and MedDRA coding
Non-toxic acute cardiogenic shock
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10007625 | Cardiogenic shock | 100000004849 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-523858-13-00 | High-dose Insulin Euglycemic Therapy in Non-Toxic Acute Cardiogenic Shock. | Oslo Universitetssykehus HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All adult patients arriving at the study sites with NTCS will be screened. Inclusion criteria: Patients with primary NTCS meet SCAI classification C, D or E (i.e. classical cardiogenic shock). These features include systolic blood pressure < 90 mmHg for > 30 minutes with appropriate fluid resuscitation with clinical and laboratory evidence of end-organ damage.
Exclusion criteria 1
- Cardiac shock etiologies where etiologies where HIET is either established therapy or considered futile: Toxic cardiogenic shock by intoxication of beta-blockers or calcium channel blockers. Acute coronary syndrome. Myocarditis. Cardiac tamponade. Pulmonary embolism. Failure to establish PAC. Failure to provide informed consent. Participation in a different RCT. Known hypersensitivity to insulin lispro or any of the excipients.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 9
- Primary exploratory efficacy endpoints at 48 hours - Changes from baseline to 48 hours in the following hemodynamic parameters using continuous pulmonary artery catheterization with thermodilution and blood sampling: cardiac output, pulmonary vascular resistance, svO2, P (v-a) CO2, lactate and N-terminal pro-B-type natriuretic peptide (NT-proBNP).
- Primary exploratory efficacy endpoints at 48 hours - Changes from baseline to 48 hours in the following echocardiographic parameters: Left ventricular ejection fraction, left ventricular outflow tract velocity time integral (LVOT VTI) and E/e’.
- Primary exploratory efficacy endpoints at 48 hours - Changes from baseline in kidney function assessed by plasma creatinine-based estimated glomerular filtration rate (eGFR), plasma urea and urine output.
- Primary exploratory efficacy endpoints at 48 hours - Changes from baseline in heartrate, mean arterial blood pressure and Sequential Organ Failure Assessment (SOFA) score.
- Primary exploratory efficacy endpoints at 48 hours - Incident hemodynamically compromising arrhythmias assessed by continuous ECG-monitoring.
- Primary exploratory efficacy endpoints at 48 hours - Total dose of vasoactive drugs, inotropic drugs and diuretics.
- Exploratory long-term endpoints at 6 weeks - Survival free of mechanical circulatory support
- Exploratory long-term endpoints at 6 weeks - Left ventricular ejection fraction assessed by echocardiography
- Exploratory long-term endpoints at 6 weeks - Kidney function assessed by eGFR and plasma urea
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Humalog 100 units/ml solution for injection in vial
PRD2457075 · Product
- Active substance
- Insulin Lispro
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 24000 IU international unit(s)
- Max total dose
- 72000 IU international unit(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10AB04 — INSULIN LISPRO
- Marketing authorisation
- EU/1/96/007/002
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Potassium Chloride MONICO 2 mEq/mL - concentrate for solution for infusion, 10 ampoules 10 mL
PRD10932423 · Product
- Active substance
- Potassium Chloride Ph. Eur.
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 750 Other
- Max total dose
- 750 Other
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA01 — POTASSIUM CHLORIDE
- Marketing authorisation
- 0
- MA holder
- MONICO S.P.A.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
GLUCOSE 50 % AGUETTANT, solution pour perfusion
PRD10393417 · Product
- Active substance
- Glucose
- Substance synonyms
- ANHYDROUS DEXTROSE, ANHYDROUS GLUCOSE, DEXTROSE (ANHYDROUS), DEXTROSE ANHYDROUS, DEXTROSE
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2000 ml millilitre(s)
- Max total dose
- 2000 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BA03 — CARBOHYDRATES
- Marketing authorisation
- 3400936253094
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo Universitetssykehus HF
- Sponsor organisation
- Oslo Universitetssykehus HF
- Address
- Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo Universitetssykehus HF
- Contact name
- Regional research support in Health South-East
Public contact point
- Organisation
- Oslo Universitetssykehus HF
- Contact name
- Regional research support in Health South-East
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2025-523858-13-01-IN-004 v1-2_Redacted | 1.2 |
| Protocol (for publication) | D1_Protocol Redacted EU CT 2025-523858-13-01 | 1 |
| Protocol (for publication) | D1_Protocol_v1-4 24 06 2026 REDUCTED | 1.4 |
| Protocol (for publication) | D1_Protocol_v1-5 | 1.5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements v1-1 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements v1-2 | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_v1-3 24 06 2026 | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF delayed v1_0 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF delayed v1-1 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF next of kin v1_0 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF next of kin v1-1 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patients adults v1_0 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF patients adults v1-1 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reservasjonsrett for bruk av helseopplysninger Next of kin v1 1 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reservasjonsrett for bruk av helseopplysninger Next of kin v1-0 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reservasjonsrett for bruk av helseopplysninger Patients v1-0 | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reservasjonsrett for bruk av helseopplysninger Patients v1-1 22 06 2026 | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Glucose | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Humalog | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Potassium Chloride | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EU CT 2025-523858-13-01-004 v1-2_Redacted | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS NO EU CT 2025-523858-13-01 Reducted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_NO | 1.4 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_NO_v1- 4_ 26 06 2026 REDU | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-19 | Norway | Acceptable 2026-07-01
|
2026-07-01 |