Non-recovery of Kidney Function After AKI

NCT05014022 | Unknown

• 2 other identifiers: 21057302569
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

One in five patients admitted to hospital suffer a sudden reduction in kidney function, termed acute kidney injury (AKI). Rather than kidney 'injury' being caused by physical trauma, the term describes reversible damage caused by conditions such as being dehydrated or having an infection. Having AKI puts patients at an increased risk of long-term health problems, especially chronic kidney disease (CKD). CKD can also lead to other important health problems including a higher risk of heart disease and stroke. If we can reduce the progression of AKI to CKD this will benefit patients. Currently, there is a gap in the follow-up of patients after AKI due to a lack of evidence about which patients should be followed up and when. Treatments for AKI during the episode and afterwards to prevent CKD are limited. This is mainly due to a lack of understanding about how and when the kidney recovers after AKI. New tools are needed in order to better identify patients at risk of CKD after AKI. This study aims to address these gaps in our knowledge by studying a group of AKI patients in detail. Ultimately, the aim of this study is to produce results that will allow better planning of follow-up for patients as well the planning of future research to develop new treatments to reduce the risk of CKD in people recovering from AKI.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Number of patients who have non-recovery of renal function after an episode of AKI

  Defined as improvement of creatinine to less than 50% above baseline i.e. reversal of AKI diagnostic criteria

  30, 60 and 90 days

Secondary Outcomes (9)

• 90 day mortality

  90 days

• Hospital readmission rates

  90 days

• Quality of life score

  90 days

• Fatigue score

  90 days

• Number of patients who have ongoing albuminuria over time

  Day 30,60 and 90

Interventions

Multiparametric renal MRI DIAGNOSTIC_TEST

10 patients in the cohort will undergo MRI scanning at day 30 and 90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital inpatients at Royal Derby Hospital across all areas.

You may qualify if:

• ≥18yrs
• Acute kidney injury stage 1-3 by KDIGO criteria
• At least one previous serum creatinine result available for determining baseline renal function
• Able to give informed consent

You may not qualify if:

• Unable to give consent or understand written information
• Obstructive uropathy
• Renal transplant
• Patient receiving palliative care
• Patient with AKI due to recent nephrectomy
• Patients with known or suspected acute vasculitis or glomerulonephritis requiring immunosuppression
• End-stage kidney disease (CKD stage G5 or already on RRT)
• Serum creatinine changes that do not meet the KDIGO definition of AKI
• MRI cohort:
• Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
• Age \< 50years old

Sponsors & Collaborators

• University of Nottingham: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples will be collected and frozen for future research.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 20, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-08