Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MR-Evaluation of Renal Function In Septic Patients (MERSEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02765191
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Sepsis, Severe Acute Kidney Injury COVID-19 Other: Plasma expansion with Ringer's Acetate Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MR-Evaluation of Renal Function In Septic Patients
Study Start Date : April 2016
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests Sepsis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    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

  2. Descriptive renal oxygenation and blood flow in critical illness due to sepsis [ Time Frame: During Critical illness - at one time point ]
    Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) during baseline measurement.

  3. Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI. [ Time Frame: During Critical illness - at one time point ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765191


Contacts
Layout table for location contacts
Contact: Tomas Luther, MD +46 6110000 tomas.luther@surgsci.uu.se

Locations
Layout table for location information
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Tomas Luther, MD    +46 6110000    tomas.luther@surgsci.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
Layout table for investigator information
Principal Investigator: Robert Frithiof, Assoc. Prof. Uppsala University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02765191    
Other Study ID Numbers: MERSEP-523-2014-2569
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Uppsala University:
Magnetic Resonance Imaging
Fluid Therapy
Renal Circulation
Renal Oxygenation
Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes