Sepsis, SevereMERSEPNCT02765191
MR-Evaluation of Renal Function In Septic Patients
A study testing Plasma expansion with Ringer's Acetate in people with Sepsis, Severe and Acute Kidney Injury, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe, Acute Kidney Injury, COVID-19
- What is being tested?
- Plasma expansion with Ringer's Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 7 Dec 2016to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sepsis, Severe, Acute Kidney Injury, COVID-19
- Being tested
- Plasma expansion with Ringer's Acetate
- Keywords
- Magnetic Resonance Imaging, Fluid Therapy, Renal Circulation, Renal Oxygenation
- Medical subject headings
- Sepsis, Acute Kidney Injury, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma expansion with Ringer's AcetateOther
7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Subjects investigated according to protocol after administration of bolus of Ringer's Acetate Receives: Other: Plasma expansion with Ringer's Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: When achieved according to protocol, approximately 3-10 minutes after intervention
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.
Measured: During Critical illness - at one time point
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.
Measured: During Critical illness - at one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start7 Dec 2016
- Primary completion10 May 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Frithiof, Assoc. Prof., Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765191
- Sponsor's protocol ID
- MERSEP-523-2014-2569
- Acronym
- MERSEP
- Status last verified
- Dec 2021
- First submitted
- 2 May 2016
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36050748
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Evaluation of Renal Function In Septic Patients
- ClinicalTrials.gov ID
- NCT02765191
- Acronym / sponsor ID
- MERSEP / MERSEP-523-2014-2569
- Conditions
- Sepsis, Severe, Acute Kidney Injury, COVID-19
- Keywords
- Magnetic Resonance Imaging, Fluid Therapy, Renal Circulation, Renal Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 7 Dec 2016 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Plasma expansion with Ringer's AcetateSubjects investigated according to protocol after administration of bolus of Ringer's Acetate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma expansion with Ringer's Acetate7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously | Other | Study group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 36050748Luther 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Frithiof, Assoc. Prof. principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma expansion with Ringer's Acetate in people with Sepsis, Severe and Acute Kidney Injury, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.