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MR-Evaluation of Renal Function In Septic Patients

MR-Evaluation of Renal Function In Septic Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02765191
Acronym
MERSEP
Enrollment
22
Registered
2016-05-06
Start date
2016-12-07
Completion date
2021-08-10
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, COVID-19, Sepsis, Severe

Keywords

Magnetic Resonance Imaging, Fluid Therapy, Renal Circulation, Renal Oxygenation

Brief summary

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

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.

Interventions

OTHERPlasma expansion with Ringer's Acetate

7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolusWhen achieved according to protocol, approximately 3-10 minutes after interventionMeasured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST), compared to baseline measurement
Descriptive renal oxygenation and blood flow in critical illness due to sepsisDuring Critical illness - at one time pointMeasured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) during baseline measurement.
Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI.During Critical illness - at one time pointMeasured 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026