NCT04594291

Brief Summary

This is a prospective observational cohort study that will aim to recruit 60 participants who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay. Potential participants will be approached either by telephone by a member of the research team or via clinics (nephrology, post-ICU follow up clinics).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

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

September 28, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

September 28, 2020

Last Update Submit

November 3, 2023

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

  • MRI assessment of global organ structure at 12 months.

    Global organ structure will be assessed through structural T1- and T2-weighted MRI scans which will provide information about automated segmentation and volume assessment of whole kidney (and both cortex and medulla) as well as other abdominal organs (including liver and spleen). Global organ structure will also be assessed through longitudinal (T1) and transverse (T2) relaxation time mapping. T1 and T2 increase with tissue inflammation, oedema and fibrosis. A respiratory-triggered inversion recovery (IR) spin-echo echo-planar scheme will be used for abdominal T1 mapping and a Gradient and spin echo (T2-GraSE) scheme for abdominal T2 mapping.

    12 months

  • MRI assessment of thrombi (R2*) at 12 months.

    R2\* data will be acquired using a multi-echo fast field echo (mFFE) scheme to assess thrombi. Conventionally R2\* mapping is used as a measure of oxygenation, but R2\*is likely to be altered by other factors in COVID-19, including oedema and small vessel thrombotic processes.

    12 months

  • MRI assessment of organ perfusion (Arterial spin labelling [ASL]) at 12 months.

    Mean transit time and perfusion depicting changes in microvascular blood flow and large vessel flow/thrombosis will be determined using a FAIR labelling scheme with a multi-slice spin-echo echo-planar imaging readout and multiple labelling delay times.

    12 months

Secondary Outcomes (22)

  • MRI assessment of global organ structure.

    3-6 and 24 months

  • MRI assessment of thrombi (R2*).

    3-6 and 24 months

  • MRI assessment of organ perfusion (ASL)

    3-6 and 24 months

  • Correlations between MRI measures with estimated glomerular filtration rate.

    3-6, 12 and 24 months

  • Correlations between MRI measures with urine albumin and protein creatinine ratios.

    3-6, 12 and 24 months

  • +17 more secondary outcomes

Interventions

MRI scansPROCEDURE

This study does not involve any intervention or new treatment. We will conduct MRI scans of the kidneys, muscles, abdomen and heart at baseline, 12 and 24 months after hospital discharge. The MRI scan will take 60-70 minutes in total.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who have had COVID-19, were admitted to hospital, required intensive care, and/or developed AKI during their hospital stay.

You may qualify if:

  • Adult patients aged 18 years or older.
  • Swab result positive for SARS-CoV-2.
  • Patients admitted to the hospital for ≥24 hrs.
  • Patients who received ICU care OR who sustained AKI stage 2/3 (as per KDIGO serum creatinine criteria).

You may not qualify if:

  • Patients \> 90 years of age.
  • Patients on haemodialysis or peritoneal dialysis or pre-existing CKD stage 5 (eGFR \<15ml/min/1.73m2).
  • Solid organ transplant.
  • Inability/refusal to give informed consent to participate.
  • Contraindications to MRI scan - claustrophobia, metal body implants, extensive tatoos, inability to lie supine for 1 hour.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Maarten Taal, Professor

    University Hospitals of Derby and Burton NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 20, 2020

Study Start

October 7, 2020

Primary Completion

March 25, 2022

Study Completion

July 31, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)