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
|Condition or disease||Intervention/treatment||Phase|
|Sepsis, Severe Acute Kidney Injury COVID-19||Other: Plasma expansion with Ringer's Acetate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Tomas Luther, MD||+46 email@example.com|
|Uppsala University Hospital||Recruiting|
|Uppsala, Sweden, 751 85|
|Contact: Tomas Luther, MD +46 6110000 firstname.lastname@example.org|
|Principal Investigator:||Robert Frithiof, Assoc. Prof.||Uppsala University|