Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
225
Countries
1
Sites
1
Patients undergoing open major abdominal surgery
Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517373-25-00
- EudraCT number
- 2022-001023-32
- ClinicalTrials.gov
- NCT05492968
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
Secondary objectives 2
- Secondary outcome 1: Brain regional oxygen saturation (brSO2) – TWA of intraoperative brSO2 values between the groups
- Secondary outcome 2: Tissue regional oxygen saturation (trSO2) – TWA of intraoperative trSO2 values between the groups
Conditions and MedDRA coding
Patients undergoing open major abdominal surgery
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Enrollment Checking for eligibility in the surgical schedule, patients' electronic records and charts. Obtaining informed consent.
|
Not Applicable | None | ||
| 2 | Intervention Patient will be randomly assigned to receive a continuous infusion of epinephrine, norepinephrine or phenylephrine for intraoperative blood pressure management.
|
Randomised Controlled | Double | [{"id":79948,"code":2,"name":"Investigator"},{"id":79946,"code":5,"name":"Carer"},{"id":79944,"code":1,"name":"Subject"},{"id":79947,"code":3,"name":"Monitor"},{"id":79945,"code":4,"name":"Analyst"}] | Epinephrine Group: Patients in the epinephrine group will receive a continuous infusion containing epinephrine with a concentration of 0.02mg.ml-1 for intraoperative blood pressure management. The infusion will be started with 0.15 mL.kg-1.h-1 and will be titrated to receive a mean arterial pressure of at least 75mmHg. Norepinephrine Group: Patients in the norepinephrine group will receive a continuous infusion containing norepinephrine with a concentration of 0.02mg.ml-1 for intraoperative blood pressure management. The infusion will be started with 0.15 mL.kg-1.h-1 and will be titrated to receive a mean arterial pressure of at least 75mmHg. Phenylephrine Group: Patients in the phenylephrine group will receive a continuous infusion containing phenylephrine with a concentration of 0.2mg.ml-1 for intraoperative blood pressure management. The infusion will be started with 0.15 mL.kg-1.h-1 and will be titrated to receive a mean arterial pressure of at least 75mmHg. |
| 3 | Outcome assessment Measurement of primary and secondary endpoints during surgery.
|
Randomised Controlled | Double | [{"id":79954,"code":1,"name":"Subject"},{"id":79950,"code":2,"name":"Investigator"},{"id":79952,"code":3,"name":"Monitor"},{"id":79951,"code":4,"name":"Analyst"},{"id":79953,"code":5,"name":"Carer"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- ≥ 45 years old
- Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least 2 hours
- ASA physical status ≥ 2
- At least one of the following risk factors (a-j): a. Age ≥ 75 years b. History of peripheral arterial disease c. History of coronary artery disease d. History of stroke or transient ischemic attack e. History of chronic kidney disease f. Diabetes requiring medical treatment g. Current smoking or history of 15 pack-years h. History of heart failure i. Preoperative high-sensitivity Troponin T ≥ 14ng.L-1 j. Preoperative NT-proBNP ≥ 200 pg.mL-1
Exclusion criteria 6
- Scheduled for pheochromocytoma surgery
- Scheduled for liver and kidney transplantation
- Requiring preoperative intravenous vasopressor medications
- Contraindications to epinephrine, norepinephrine or phenylephrine per clinical judgement
- Permanent atrial fibrillation
- Preoperative heart rate >110 bpm
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
Secondary endpoints 2
- Secondary outcome 1: Brain regional oxygen saturation (brSO2) – TWA of intraoperative brSO2 values between the groups
- Secondary outcome 2: Tissue regional oxygen saturation (trSO2) – TWA of intraoperative trSO2 values between the groups
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8531615 · Product
- Active substance
- Epinephrine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA24 — EPINEPHRINE
- Marketing authorisation
- 3.416
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Noradrenalin Kabi 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD9253083 · Product
- Active substance
- Noradrenaline Tartrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA03 — NOREPINEPHRINE
- Marketing authorisation
- 140619
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Biorphen 10 mg/ml Injektionslösung
PRD4891231 · Product
- Active substance
- Phenylephrine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA06 — PHENYLEPHRINE
- Marketing authorisation
- 137540
- MA holder
- SINTETICA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of General Anaesthesia and Intensive Care Medicine
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of General Anaesthesia and Intensive Care Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 225 | 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 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517373-25-00 blinded | 1.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements blinded | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults blinded | 1.4 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB Biorphen | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB Noradrenalin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB Suprarenin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-517373-25-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-25 | Austria | Acceptable 2024-10-09
|
2024-10-14 |