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

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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

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date June 17, 2020
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Change in RBF at MAP 75-80 [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    Measured with ASL, compared to baseline measurement
  • Change in RBF after standardized fluid bolus [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    Measured with ASL, compared to baseline measurement
  • Change in RBF after standardized fluid bolus at MAP 75-80 [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    Measured with ASL, compared to baseline measurement
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2016)
  • Change in renal oxygenation at MAP 75-80 [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    Measured with BOLD, compared to baseline measurement
  • Change in renal oxygenation after standardized fluid bolus [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    Measured with BOLD, compared to baseline measurement
  • Change in renal oxygenation after standardized fluid bolus at MAP 75-80 [ Time Frame: When achieved according to protocol, approximately 3-10 minutes after intervention ]
    Measured with BOLD, compared to baseline measurement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MR-Evaluation of Renal Function In Septic Patients
Official Title  ICMJE MR-Evaluation of Renal Function In Septic Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Sepsis, Severe
  • Acute Kidney Injury
  • COVID-19
Intervention  ICMJE Other: Plasma expansion with Ringer's Acetate
7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously
Study Arms  ICMJE Experimental: Study group
Subjects investigated according to protocol after administration of bolus of Ringer's Acetate
Intervention: Other: Plasma expansion with Ringer's Acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tomas Luther, MD +46 6110000 tomas.luther@surgsci.uu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02765191
Other Study ID Numbers  ICMJE MERSEP-523-2014-2569
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Frithiof, Assoc. Prof. Uppsala University
PRS Account Uppsala University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP