MR-Evaluation of Renal Function In Septic Patients

COVID-19 Clinical Trial

— MERSEP  

Official title:

MR-Evaluation of Renal Function In Septic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765191
• Other study ID #: MERSEP-523-2014-2569
• Status: Completed
• Phase: N/A
• Start date: December 7, 2016
• Est. completion date: August 10, 2021

Study information

• Verified date: December 2021
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Plasma expansion with Ringer's Acetate
7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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