MR-Evaluation of Renal Function In Septic Patients

NCT ID: NCT02765191

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-07
• Study Completion Date: 2021-08-10

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.

Conditions

Sepsis, Severe; Acute Kidney Injury; COVID-19

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study group

Subjects investigated according to protocol after administration of bolus of Ringer's Acetate

Group Type: EXPERIMENTAL

Plasma expansion with Ringer's Acetate

Intervention Type: OTHER

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

Interventions

Plasma expansion with Ringer's Acetate

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Frithiof, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University Hospital

Uppsala, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 36050748 (View on PubMed)

Other Identifiers

MERSEP-523-2014-2569

Identifier Type: -

Identifier Source: org_study_id