Renal Blood FlowPhase 4MERAPEDNCT06876870
MR-Evaluation of Renal Function in Anesthetized Pediatric Patients
A Phase 4 study testing Anesthesia Maintenance Agent in people with Renal Blood Flow and Anesthesia, run by Uppsala University.
Trial summary
The goal of this study is to investigate the effect of the anesthetic agents sevoflurane or propofol on the blood flow and oxygen delivery to the kidneys. Pediatric patients who are planned to undergo an MRI scan with generalized anesthesia will be randomized to either IV anesthesia with propofol or inhalation… Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Renal Blood Flow, Anesthesia, MRI
- What is being tested?
- Anesthesia Maintenance Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 20 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric Patients (1 month -14 years of age)
- Indicated for MRI with anesthesia
- ASA (American Society of Anesthesiologists) physical status I-III
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Robert Frithiof, Professor contact
About this study
The goal of this study is to investigate the effect of the anesthetic agents sevoflurane or propofol on the blood flow and oxygen delivery to the kidneys.
Pediatric patients who are planned to undergo an MRI scan with generalized anesthesia will be randomized to either IV anesthesia with propofol or inhalation anesthesia with sevoflurane. Both of these anesthetic methods are commonly used for anesthesia on an everyday basis.
In addition to the clinically indicated MRI, Multiparametric MRI will be performed to visualize the effect of the anesthetic agent on renal blood flow, perfusion and oxygenation.
Read the detailed description
See the study protocol
- Conditions
- Renal Blood Flow, Anesthesia, MRI, Renal Oxygenation
- Being tested
- Anesthesia Maintenance Agent
- Keywords
- Renal Blood flow, Anesthesia, Pediatric, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia Maintenance AgentDrug
Also called Anesthesia, Sevoflurane, Propofol
Difference in renal blood flow (RBF) between Propofol and Sevoflurane groups. Quantified by specific Multiparametric MRI metrics (e.g., (Renal blood flow by phase contrast imaging) (regional perfusion by Arterial Spin labeling (ASL) and global and regional oxygenation by Blood oxygen dependent signal (BOLD))
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol Maintenance Anesthesia Receives: Drug: Anesthesia Maintenance Agent |
| Sevoflurane | Active comparator | Sevoflurane Maintenance Anesthesia Receives: Drug: Anesthesia Maintenance Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in RBF, as measured by phase contrast imaging with mpMRI, between propofol and sevoflurane anesthesia.
Multiparametric MRI via phase contrast imaging to quantify renal blood flow, will be standardized to renal area. By quantifying renal blood flow we will be able to evaluate the effects of propofol and sevoflurane on RBF.
Measured: The extra imaging is expected to take 20-30 minutes.
Secondary outcomes (4)
Differences in regional renal tissue perfusion, as measured by arterial spin labelling (ASL) with mpMRI, between propofol and sevoflurane anaesthesia
To investigate the effect of Propofol and Sevoflurane on regional tissue perfusion in the renal cortex and medulla.
Measured: The whole MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
Differences in regional and global renal oxygenation, as measured by Blood Oxygen Level Dependent (BOLD) signal via mpMRI, between propofol and sevoflurane anaesthesia.
To explore potential differences related to the Sevoflurane or Propofol on regional and global renal oxygenation.
Measured: The whole MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
The difference in relation of RBF to systemic non-invasive blood pressure, between propofol and sevoflurane anaesthesia
To investigate how RBF varies in relation to systemic blood pressure in paediatric patients in generalized anaesthesia with propofol or Sevoflurane.
Measured: The entire MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
The difference plasma renin concentration, measured by a blood sample, between propofol and sevoflurane anaesthesia
To explore the effect of Sevoflurane and Propofol on serum Renin concentration as a surrogate marker for Renal sympathetic nerve activation.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Blood FlowStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized to one out of two possible methods of maintenance anesthesia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Frithiof, Professor, Study chair, Istitution of Surgical Sciences, Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876870
- Sponsor's protocol ID
- MERAPED
- Other IDs
- 2025-520627-25-00, 2025
- Acronym
- MERAPED
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Evaluation of Renal Function in Anesthetized Pediatric Patients
- ClinicalTrials.gov ID
- NCT06876870
- Acronym / sponsor ID
- MERAPED / MERAPED
- Conditions
- Renal Blood Flow, Anesthesia, MRI, Renal Oxygenation
- Keywords
- Renal Blood flow, Anesthesia, Pediatric, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate the effect of the anesthetic agents sevoflurane or propofol on the blood flow and oxygen delivery to the kidneys.
Pediatric patients who are planned to undergo an MRI scan with generalized anesthesia will be randomized to either IV anesthesia with propofol or inhalation anesthesia with sevoflurane. Both of these anesthetic methods are commonly used for anesthesia on an everyday basis.
In addition to the clinically indicated MRI, Multiparametric MRI will be performed to visualize the effect of the anesthetic agent on renal blood flow, perfusion and oxygenation.
Detailed description
See the study protocol
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to one out of two possible methods of maintenance anesthesia
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Anesthesia Maintenance AgentPropofol Maintenance Anesthesia |
| Sevoflurane | Active comparator | Drug: Anesthesia Maintenance AgentSevoflurane Maintenance Anesthesia |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric Patients (1 month -14 years of age)
- Indicated for MRI with anesthesia
- ASA (American Society of Anesthesiologists) physical status I-III
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia Maintenance AgentAlso: Anesthesia, Sevoflurane, PropofolDifference in renal blood flow (RBF) between Propofol and Sevoflurane groups. Quantified by specific Multiparametric MRI metrics (e.g., (Renal blood flow by phase contrast imaging) (regional perfusion by Arterial Spin labeling (ASL) and global and regional oxygenation by Blood oxygen dependent signal (BOLD)) | Drug | Propofol, Sevoflurane |
Primary outcome
Differences in RBF, as measured by phase contrast imaging with mpMRI, between propofol and sevoflurane anesthesia.
Time frame: The extra imaging is expected to take 20-30 minutes.
Multiparametric MRI via phase contrast imaging to quantify renal blood flow, will be standardized to renal area. By quantifying renal blood flow we will be able to evaluate the effects of propofol and sevoflurane on RBF.
4 secondary outcomes
Differences in regional renal tissue perfusion, as measured by arterial spin labelling (ASL) with mpMRI, between propofol and sevoflurane anaesthesia
Time frame: The whole MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
Differences in regional and global renal oxygenation, as measured by Blood Oxygen Level Dependent (BOLD) signal via mpMRI, between propofol and sevoflurane anaesthesia.
Time frame: The whole MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
The difference in relation of RBF to systemic non-invasive blood pressure, between propofol and sevoflurane anaesthesia
Time frame: The entire MpMRI will take around 20-30 minutes all together where the primary and secondary outcomes can later be extracted via analysis of the images
The difference plasma renin concentration, measured by a blood sample, between propofol and sevoflurane anaesthesia
Time frame: 1 minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No. GDPR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Frithiof, Professor contact
Robert Frithiof, Professor study chair
Istitution of Surgical Sciences, Anesthesiology and Intensive Care
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anesthesia Maintenance Agent in people with Renal Blood Flow and Anesthesia, run by Uppsala University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arash Emami, PhD student (+46763222722, arash.emami@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in RBF, as measured by phase contrast imaging with mpMRI, between propofol and sevoflurane anesthesia. (time frame: The extra imaging is expected to take 20-30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.