MR-Evaluation of Renal Function in Anesthetized Pediatric Patients (MERAPED)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MRI; Anesthesia; Renal Blood Flow; Renal Oxygenation
• Intervention / Treatment: Drug: Anesthesia Maintenance Agent

Detailed Description

See the study protocol

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Arash Emami, PhD student; Phone Number: +46763222722; Email: arash.emami@uu.se
• Study Contact Backup: Name: Robert Frithiof, Professor; Email: robert.frithiof@uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric Patients (1 month -14 years of age)
• Indicated for MRI with anesthesia
• ASA (American Society of Anesthesiologists) physical status I-III

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; Propofol Maintenance Anesthesia	Drug: Anesthesia Maintenance Agent; 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)); Other Names: Anesthesia; Sevoflurane; Propofol
Active Comparator: Sevoflurane; Sevoflurane Maintenance Anesthesia	Drug: Anesthesia Maintenance Agent; 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)); Other Names: Anesthesia; Sevoflurane; Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The extra imaging is expected to take 20-30 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	1 minute

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Uppsala University Hospital
• Investigators: Study Chair: Robert Frithiof, Professor, Istitution of Surgical Sciences, Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): June 20, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MRI; Pediatric; Anesthesia; Renal Blood flow
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane; Anesthetics; Propofol
• Other Study ID Numbers: MERAPED; 2025-520627-25-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GDPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No