NCT02765191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

December 7, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

4.4 years

First QC Date

May 2, 2016

Last Update Submit

December 3, 2021

Conditions

Sepsis, SevereAcute Kidney InjuryCOVID-19

Keywords

Magnetic Resonance ImagingFluid TherapyRenal CirculationRenal Oxygenation

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    During Critical illness - at one time point

Study Arms (1)

Study group

EXPERIMENTAL

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

Other: Plasma expansion with Ringer's Acetate

Interventions

Plasma expansion with Ringer's AcetateOTHER

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

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical diagnosis sepsis (infection and organ dysfuncion) treated in intensive care.
  • Manifest Acute kidney injury (AKI) or risk of AKI.
  • years of age or older

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 36050748DERIVED

MeSH Terms

Conditions

SepsisAcute Kidney InjuryCOVID-19

Interventions

Ringer's acetate

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Robert Frithiof, Assoc. Prof.

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 6, 2016

Study Start

December 7, 2016

Primary Completion

May 10, 2021

Study Completion

August 10, 2021

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)