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

• ClinicalTrials.gov Identifier: NCT02765191
• Recruitment Status: Recruiting
• First Posted: May 6, 2016
• Last Update Posted: June 17, 2020
• Sponsor: Uppsala University
• Information provided by (Responsible Party): Uppsala University

Tracking Information

• First Submitted Date: May 2, 2016
• First Posted Date: May 6, 2016
• Last Update Posted Date: June 17, 2020
• Study Start Date: April 2016
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: MR-Evaluation of Renal Function In Septic Patients
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

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

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 4, 2016): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2025
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tomas Luther, MD; +46 6110000; tomas.luther@surgsci.uu.se

• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02765191
• Other Study ID Numbers: MERSEP-523-2014-2569
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Uppsala University
• Study Sponsor: Uppsala University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Frithiof, Assoc. Prof.; Uppsala University

• PRS Account: Uppsala University
• Verification Date: June 2020