MERSEP: MR-Evaluation of Renal Function In Septic Patients

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT02765191

Collaborator

(none)

Enrollment

Location

Arm

56.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis, Severe Acute Kidney Injury COVID-19	Other: Plasma expansion with Ringer's Acetate	N/A

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

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

MR-Evaluation of Renal Function In Septic Patients

Actual Study Start Date :

Dec 7, 2016

Actual Primary Completion Date :

May 10, 2021

Actual Study Completion Date :

Aug 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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