Overview
Sponsor-declared trial summary
To evaluate the effects of sevoflurane administration intra- (including the period of extracorporeal circulation ischemia) and postoperatively in patients undergoing double valve surgery with respect to propofol in terms of reducing myocardial damage and injury. For this, the levels of NT-ProBNP and troponin I will be measured; and its impact on myocardial preservation, through the measurement of the cardiac index intraoperatively and immediately postoperatively, as well as the use of inotropes for low cardiac output syndrome.
To evaluate the effects of sevoflurane administration intra- (including the period of extracorporeal circulation ischemia) and postoperatively in patients undergoing double valve surgery with respect to propofol in terms of reducing myocardial damage and injury. For this, the levels of NT-ProBNP and troponin I will be …
Key facts
- Sponsor
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520812-33-00
- EudraCT number
- 2022-003638-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the effects of sevoflurane administration intra- (including the period of extracorporeal circulation ischemia) and postoperatively in patients undergoing double valve surgery with respect to propofol in terms of reducing myocardial damage and injury. For this, the levels of NT-ProBNP and troponin I will be measured; and its impact on myocardial preservation, through the measurement of the cardiac index intraoperatively and immediately postoperatively, as well as the use of inotropes for low cardiac output syndrome.
Secondary objectives 1
- To evaluate whether there is a relationship between the new circRNA biomarkers, in their basal expression, and their variation at 24 hours with the clinical conditions evaluated (cardiac or renal dysfunction). To evaluate whether there is a relationship between the new circRNA biomarkers, in their basal expression, and their variation at 24 hours between the different treatment groups (evaluating their variation with those of fundamental enzymes in myocardial conditioning pathways).
Conditions and MedDRA coding
To evaluate the effects of sevoflurane administration intra- (including the period of extracorporeal circulation ischemia) and postoperatively in patients undergoing double valve surgery with respect to propofol in terms of reducing myocardial damage and injury. For this, the levels of NT-ProBNP and troponin I will be measured; and its impact on myocardial preservation, through the measurement of the cardiac index intraoperatively and immediately postoperatively, as well as the use of inotropes for low cardiac output syndrome.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Age ≥ 18 years. 2. Elective surgery cardiac surgery with double valve pump. 3. Use of Nido cardioplegia, common in this type of patient
Exclusion criteria 1
- 1. History of adverse reaction to sevoflurane or propofol. 2. Severe disease of any organ (lung, liver, kidney), diagnosed preoperatively. 3. Combined surgery (e.g. coronary or carotid surgery). 4. Patients in a situation of hemodynamic instability. 5. Heart failure or need to use inotropic or vasoactive drugs prior to the intervention. 6. Treatment with oral antidiabetics not suspended at least 48 hours before. 7. Treatment with euphylline/theophylline prior to the intervention. 8. Inability to grant informed consent. 9. Pregnancy or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evaluation variables: Sex, age, Cardiac index, creatinine, N-GAL, Stroke Volume index, heart rate, beats / min, mean arterial pressure, right ventricular end-diastolic pressure, Troponin I, NT-ProBNP, pre/postconditioning enzymes, renal dysfunction, inotropic support, days of ICU stay and circRNA values
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Propofol Eignapharma 10 mg/ml Emulsão injetável/para perfusão
PRD11503999 · Product
- Active substance
- Propofol
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INFUSIÓN INTRAVENOSA
- Max daily dose
- 500 mg/ml milligram(s)/millilitre
- Max total dose
- 500 mg/ml milligram(s)/millilitre
- Max treatment duration
- 500 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 5886213
- MA holder
- EIGNAPHARMA SLU
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Sponsor organisation
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Address
- Calle De Severo Ochoa 35, Parque Tecnologico De Andalucia Parque Tecnologico De Andalucia
- City
- Malaga
- Postcode
- 29590
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Contact name
- Elvira Bonilla
Public contact point
- Organisation
- Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
- Contact name
- Elvira Bonilla
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 70 | 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 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 04 Protocolo | 1 |
| Recruitment arrangements (for publication) | 04 Protocolo | 1 |
| Recruitment arrangements (for publication) | 2022-003638-38_Autorizacion Ensayo | 1 |
| Subject information and informed consent form (for publication) | CIsas 2021 | 1 |
| Subject information and informed consent form (for publication) | HIP Y CI donacion de muestras a biobanco | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SEVOFL | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-24 | Spain | Acceptable with conditions 2025-01-27
|
2025-01-27 |