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Completed

NCT Number: NCT02765191

MR-Evaluation of Renal Function In Septic Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Plasma expansion with Ringer's Acetate

Other

7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Acronym: MERSEP

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 6, 2016
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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