Clinical trial NCT02765191: MR-Evaluation of Renal Function In Septic Patients
Official title: MR-Evaluation of Renal Function In Septic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis, Severe
Acute Kidney Injury
COVID-19
Keywords: Magnetic Resonance Imaging
Fluid Therapy
Renal Circulation
Renal Oxygenation
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus
timeFrame: When achieved according to protocol, approximately 3-10 minutes after intervention
measure: Descriptive renal oxygenation and blood flow in critical illness due to sepsis
timeFrame: During Critical illness - at one time point
measure: Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI.
timeFrame: During Critical illness - at one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Robert Frithiof, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luther T, Eckerbom P, Cox E, Lipcsey M, Bulow S, Hultstrom 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.