search
Back to results

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

Primary Purpose

Sepsis, Severe, Acute Kidney Injury, COVID-19

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Plasma expansion with Ringer's Acetate
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sepsis, Severe focused on measuring Magnetic Resonance Imaging, Fluid Therapy, Renal Circulation, Renal Oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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

Outcomes

Primary Outcome Measures

Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2016
Last Updated
December 3, 2021
Sponsor
Uppsala University
search

1. Study Identification

Unique Protocol Identification Number
NCT02765191
Brief Title
MR-Evaluation of Renal Function In Septic Patients
Acronym
MERSEP
Official Title
MR-Evaluation of Renal Function In Septic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2016 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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; at baseline after stabilization after intravenous infusion of 7,5 ml/kg mL Ringer's acetate The following data will be registered: Age, gender, length and weight, concomitant diseases and treatment, present disease and treatment, source of admission - emergency department or ordinary ward, daily laboratory reports, results from other investigations, e.g. x-rays, cultures etc., recordings from the intensive care unit (ICU) monitors Continuous renal replacement therapy (CRRT) - duration type, flow rate, replacement fluid, etc. dead or alive at discharge and 90 days mortality, renal function at discharge, treatment restrictions, if the patient has died, the results from a possible postmortem examination. As well as all data obtained during the MRI-examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Severe, Acute Kidney Injury, COVID-19
Keywords
Magnetic Resonance Imaging, Fluid Therapy, Renal Circulation, Renal Oxygenation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Subjects investigated according to protocol after administration of bolus of Ringer's Acetate
Intervention Type
Other
Intervention Name(s)
Plasma expansion with Ringer's Acetate
Intervention Description
7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously
Primary Outcome Measure Information:
Title
Change in renal blood flow and renal oxygenation after standardized plasma expansion with fluid bolus
Description
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
Time Frame
When achieved according to protocol, approximately 3-10 minutes after intervention
Title
Descriptive renal oxygenation and blood flow in critical illness due to sepsis
Description
Measured with arterial spin labelling (ASL), Phase Contras, Blood oxygenation level dependent (BOLD) and T(2) -Relaxation-Under-Spin-Tagging (TRUST) during baseline measurement.
Time Frame
During Critical illness - at one time point
Title
Descriptive renal oxygenation and blood flow in critical illness in no/low grade AKI or high grade AKI.
Description
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.
Time Frame
During Critical illness - at one time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Frithiof, Assoc. Prof.
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36050748
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.
Results Reference
derived

Learn more about this trial

MR-Evaluation of Renal Function In Septic Patients

We'll reach out to this number within 24 hrs