Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
50
Countries
1
Sites
1
Post-operative Acute Kidney Injury
To evaluate the effects of Propofol and Sevoflurane on Renal Blood Flow (RBF) in paediatric patients
Key facts
- Sponsor
- Region Uppsala
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07], Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-09-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520627-25-00
- ClinicalTrials.gov
- NCT06876870
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic
To evaluate the effects of Propofol and Sevoflurane on Renal Blood Flow (RBF) in paediatric patients
Secondary objectives 4
- To explore the effect of Sevoflurane and Propofol on serum Renin concentration as a surrogate marker for Renal sympathetic nerve activation.
- To investigate how RBF varies in relation to systemic blood pressure in paediatric patients in generalized anaesthesia with propofol or Sevoflurane
- To explore potential differences related to the Sevoflurane or Propofol on regional and global renal oxygenation.
- To investigate the effect of Propofol and Sevoflurane on regional tissue perfusion in the renal cortex and medulla
Conditions and MedDRA coding
Post-operative Acute Kidney Injury
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Pediatric Patients (1 month -14 years of age)
- Indicated for MRI with anesthesia
- ASA (American Society of Anesthesiologists) physical status I-III
Exclusion criteria 8
- Known renal impairment or chronic kidney disease
- Severe cardiac or pulmonary disease
- Allergy to either Propofol or Sevoflurane
- Contraindications to Magnetic Resonance Imaging
- Contraindications to either Propofol or Sevoflurane
- Declined participation or declined consent from patients, parents or guardians.
- Ongoing acute kidney injury
- Pregnancy. Female participants of childbearing potential (defined as post-menarche) will be excluded if pregnant, confirmed by asking about menstrual and pregnancy status.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Differences in RBF, as measured by phase contrast imaging with mpMRI, between propofol and sevoflurane anesthesia.
Secondary endpoints 4
- The difference plasma renin concentration, measured by a blood sample, between propofol and sevoflurane anaesthesia
- The difference in relation of RBF to systemic non-invasive blood pressure, between propofol and sevoflurane anaesthesia
- Differences in regional and global renal oxygenation, as measured by Blood Oxygen Level Dependent (BOLD) signal via mpMRI, between propofol and sevoflurane anaesthesia.
- Differences in regional renal tissue perfusion, as measured by arterial spin labelling (ASL) with mpMRI, between propofol and sevoflurane anaesthesia
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP12667971 · ATC
- Active substance
- Propofol
- Substance synonyms
- 2,6-Bis(PROPAN-2-YL)PHENOL, ICI-35868, DISOPROFOL
- Route of administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Max daily dose
- 14 mg/kg/h milligram(s)/kilogram/hour
- Max total dose
- 14 mg/kg/h milligram(s)/kilogram/hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP151708 · ATC
- Active substance
- Sevoflurane
- Route of administration
- INHALATION
- Max daily dose
- 5 % percent
- Max total dose
- 5 % percent
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AB08 — SEVOFLURANE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Uppsala
- Sponsor organisation
- Region Uppsala
- Address
- Storgatan 27, Uppsala Domkyrkofors Uppsala Domkyrkofors
- City
- Uppsala
- Postcode
- 753 31
- Country
- Sweden
Scientific contact point
- Organisation
- Region Uppsala
- Contact name
- Robert Frithiof
Public contact point
- Organisation
- Region Uppsala
- Contact name
- Pia Stöllman
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 50 | 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 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CRF MARVEL | 1 |
| Recruitment arrangements (for publication) | forfarande-for-rekrytering-och-samtyckesprocess MARVEL | 1 |
| Subject information and informed consent form (for publication) | Information 12-14 ar | 1 |
| Subject information and informed consent form (for publication) | Information 6-12 ar | 1 |
| Subject information and informed consent form (for publication) | Information till vardnadshavare | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Propofol Sandoz emulsion for injection and infusion ENG SmPC_09001bee83a3b561 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Sevofluran Baxter inhalation vapour Svenska SmPCpdf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Sevoflurane | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SV Propofol-Lipuro 10 mg per ml emulsion for injection or infusion SmPC_09001bee807a7b22-3 | 1 |
| Synopsis of the protocol (for publication) | Provningsprotokoll MARVEL | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-26 | Sweden | Acceptable 2025-09-26
|
2025-09-26 |