MR-Evaluation of Renal Function In Septic Patients (MERSEP)

A study of renal blood flow and renal oxygenation measured by magnetic resonance after a standardized fluid challenge in critically ill, resuscitated, patients with sepsis due to COVID-19 or other agents.

Study Overview

• Status: Completed
• Conditions: COVID-19; Acute Kidney Injury; Sepsis, Severe
• Intervention / Treatment: Other: Plasma expansion with Ringer's Acetate

Detailed Description

Critically ill, septic patients with or without acute kidney injury (AKI) above 18 years of age who have been circulatory and respiratory stabilized will be screened for inclusion.

After the patients have been adequately treated with antimicrobial agents, source control and circulatory and respiratory stabilized, the patient will be moved to the Magnetic resonance imaging (MRI)-suite and placed in the MRI-camera. We plan to, at the same time, study renal blood flow (RBF) and oxygenation with 4 different MRI techniques; arterial spin labeling (ASL), Blood oxygen level dependent (BOLD)-technique, T(2) -Relaxation-Under-Spin-Tagging (TRUST) and Phase contrast at two conditions;

1. at baseline after stabilization
2. after intravenous infusion of 7,5 ml/kg mL Ringer's acetate

The following data will be registered:

1. Age, gender, length and weight,
2. concomitant diseases and treatment,
3. present disease and treatment,
4. source of admission - emergency department or ordinary ward,
5. daily laboratory reports,
6. results from other investigations, e.g. x-rays, cultures etc.,
7. recordings from the intensive care unit (ICU) monitors
8. Continuous renal replacement therapy (CRRT) - duration type, flow rate, replacement fluid, etc.
9. dead or alive at discharge and 90 days mortality,
10. renal function at discharge,
11. treatment restrictions,
12. if the patient has died, the results from a possible postmortem examination. As well as all data obtained during the MRI-examination.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with clinical diagnosis sepsis (infection and organ dysfuncion) treated in intensive care.
• Manifest Acute kidney injury (AKI) or risk of AKI.
• 18 years of age or older

Exclusion Criteria:

• Pregnancy
• Chronic kidney failure
• Renal Replacement Therapy
• Instability in vital parameters to a degree where MRI is not feasible
• Contraindications for MRI (implants, coils, pacemakers, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Subjects investigated according to protocol after administration of bolus of Ringer's Acetate	Other: Plasma expansion with Ringer's Acetate; 7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus	Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST), compared to baseline measurement	When achieved according to protocol, approximately 3-10 minutes after intervention
Descriptive renal oxygenation and blood flow in critical illness due to sepsis	Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) during baseline measurement.	During Critical illness - at one time point
Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI.	Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) images stratified in groups in regards to KDIGO grade during exam.	During Critical illness - at one time point

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Robert Frithiof, Assoc. Prof., Uppsala University

Publications and helpful links

General Publications

• Luther T, Eckerbom P, Cox E, Lipcsey M, Bülow S, Hultström M, Torrente FM, Weis J, Palm F, Francis S, Frithiof R, Liss P. Decreased renal perfusion during acute kidney injury in critical COVID-19 assessed by magnetic resonance imaging: a prospective case control study. Crit Care. 2022 Sep 1;26(1):262. doi: 10.1186/s13054-022-04132-8.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2016
• Primary Completion (Actual): May 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Fluid Therapy; Renal Circulation; Renal Oxygenation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Sepsis; Acute Kidney Injury
• Other Study ID Numbers: MERSEP-523-2014-2569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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