Clinical trial • Phase IV • Other

EPINEPHRINE HYDROCHLORIDE for Major open abdominal surgery

Phase IV trial of EPINEPHRINE HYDROCHLORIDE for Major open abdominal surgery.

Overview

Trial Therapeutic Area: Other
Trial Disease: Major open abdominal surgery
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 25-08-2024
First CTIS Authorization Date: 14-10-2024

Trial design

Randomised, epinephrine group: continuous infusion containing epinephrine at 0.02 mg·ml-1, started at 0.15 ml·kg-1·h-1 and titrated to achieve mean arterial pressure ≥75 mmhg. norepinephrine group: continuous infusion containing norepinephrine at 0.02 mg·ml-1, started at 0.15 ml·kg-1·h-1 and titrated to achieve mean arterial pressure ≥75 mmhg. phenylephrine group: continuous infusion containing phenylephrine at 0.2 mg·ml-1, started at 0.15 ml·kg-1·h-1 and titrated to achieve mean arterial pressure ≥75 mmhg.-controlled Phase IV trial across 1 site in Austria.

Randomised: Yes
Comparator: Epinephrine Group: continuous infusion containing epinephrine at 0.02 mg·ml-1, started at 0.15 mL·kg-1·h-1 and titrated to achieve mean arterial pressure ≥75 mmHg. Norepinephrine Group: continuous infusion containing norepinephrine at 0.02 mg·ml-1, started at 0.15 mL·kg-1·h-1 and titrated to achieve mean arterial pressure ≥75 mmHg. Phenylephrine Group: continuous infusion containing phenylephrine at 0.2 mg·ml-1, started at 0.15 mL·kg-1·h-1 and titrated to achieve mean arterial pressure ≥75 mmHg.
Target Sample Size: 225
Trial Duration For Participant: 1

Eligibility

Recruits 225 No vulnerable population selected. Informed consent will be obtained from adult participants (Enrollment: "Checking for eligibility in the surgical schedule, patients' electronic records and charts. Obtaining informed consent."). No assent or paediatric consent procedures are indicated..

Vulnerable Population: No vulnerable population selected. Informed consent will be obtained from adult participants (Enrollment: "Checking for eligibility in the surgical schedule, patients' electronic records and charts. Obtaining informed consent."). No assent or paediatric consent procedures are indicated.

Inclusion criteria

{"criterion_text":"- ≥ 45 years old\n- Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least 2 hours\n- ASA physical status ≥ 2\n- 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

{"criterion_text":"- Scheduled for pheochromocytoma surgery\n- Scheduled for liver and kidney transplantation\n- Requiring preoperative intravenous vasopressor medications\n- Contraindications to epinephrine, norepinephrine or phenylephrine per clinical judgement\n- Permanent atrial fibrillation\n- Preoperative heart rate >110 bpm"}

Endpoints

Primary endpoints

{"endpoint_text":"- Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.","definition_or_measurement_approach":"Time-weighted average of cardiac output measured intraoperatively during surgery (primary and secondary endpoints measured during surgery; primaryEndPoints entry as stated)."}

Secondary endpoints

{"endpoint_text":"- Secondary outcome 1: Brain regional oxygen saturation (brSO2) – TWA of intraoperative brSO2 values between the groups","definition_or_measurement_approach":"Time-weighted average of intraoperative brain regional oxygen saturation (brSO2) measured during surgery."}
{"endpoint_text":"- Secondary outcome 2: Tissue regional oxygen saturation (trSO2) – TWA of intraoperative trSO2 values between the groups","definition_or_measurement_approach":"Time-weighted average of intraoperative tissue regional oxygen saturation (trSO2) measured during surgery."}

Recruitment

Planned Sample Size: 225
Recruitment Window Months: 39
Consent Approach: Informed consent will be obtained from adult participants. A subject information sheet and informed consent form for adults is listed in the documents (L1_SIS and ICF adults blinded). No paediatric consent/assent procedures specified; languages not specified.

Methods

Checking for eligibility in the surgical schedule, patients' electronic records and charts at participating site(s) (hospital-based screening).
Obtaining informed consent from eligible patients at the site (hospital/clinic).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 225

Austria

Earliest CTIS Part Ii Submission Date: 06-09-2024
Latest Decision Or Authorization Date: 14-10-2024
Processing Time Days: 38
Number Of Sites: 1
Number Of Participants: 225

Sites

Site Name: Medical University Of Vienna
Department Name: Division of General Anaesthesia and Intensive Care Medicine
Principal Investigator Name: Christian Reiterer
Principal Investigator Email: christian.reiterer@meduniwien.ac.at
Contact Person Name: Christian Reiterer
Contact Person Email: christian.reiterer@meduniwien.ac.at
Number Of Participants: 225

Sponsor

Primary sponsor

Full Name: Medical University Of Vienna
Organisation Type: Educational Institution
Country Of Registered Address: Austria

Investigational products

Investigational Product Name: Suprarenin 1mg/ml Ampullen
Active Substance: EPINEPHRINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Starting Dose: Concentration 0.02 mg·ml-1; infusion started at 0.15 mL·kg-1·h-1, titrated to MAP ≥75 mmHg
Frequency: Continuous infusion (titrated)
Maximum Dose: 10 mg (maxTotalDoseAmount: 10)

Investigational Product Name: Noradrenalin Kabi 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance: NORADRENALINE TARTRATE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Starting Dose: Concentration 0.02 mg·ml-1; infusion started at 0.15 mL·kg-1·h-1, titrated to MAP ≥75 mmHg
Frequency: Continuous infusion (titrated)
Maximum Dose: 10 mg (maxTotalDoseAmount: 10)

Investigational Product Name: Biorphen 10 mg/ml Injektionslösung
Active Substance: PHENYLEPHRINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: Intravenous infusion
Authorisation Status: Authorised
Starting Dose: Concentration 0.2 mg·ml-1; infusion started at 0.15 mL·kg-1·h-1, titrated to MAP ≥75 mmHg
Frequency: Continuous infusion (titrated)
Maximum Dose: 100 mg (maxTotalDoseAmount: 100)

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