MR-Evaluation of Renal Function In Septic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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; at baseline after stabilization after intravenous infusion of 7,5 ml/kg mL Ringer's acetate The following data will be registered: Age, gender, length and weight, concomitant diseases and treatment, present disease and treatment, source of admission - emergency department or ordinary ward, daily laboratory reports, results from other investigations, e.g. x-rays, cultures etc., recordings from the intensive care unit (ICU) monitors Continuous renal replacement therapy (CRRT) - duration type, flow rate, replacement fluid, etc. dead or alive at discharge and 90 days mortality, renal function at discharge, treatment restrictions, if the patient has died, the results from a possible postmortem examination. As well as all data obtained during the MRI-examination.

Official Title
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MR-Evaluation of Renal Function In Septic Patients

Conditions
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Sepsis, Severe, Acute Kidney Injury, COVID-19

Intervention / Treatment
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* Other: Plasma expansion with Ringer's Acetate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Fluid Therapy, Renal Circulation, Renal Oxygenation