NCT05740709

Brief Summary

The investigators will investigate whether new kidney biomarkers can identify patients who are at risk of chronic kidney disease after an episode of moderate / severe acute kidney injury in ICU.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 10, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.8 years

First QC Date

October 10, 2022

Last Update Submit

January 22, 2024

Conditions

Keywords

acute kidney injurychronic kidney diseasekidney biomarkers

Outcome Measures

Primary Outcomes (1)

  • serum creatinine

    estimated glomerular filtration rate (eGFR) \<60ml/min

    3 months after discharge from hospital

Secondary Outcomes (3)

  • mortality

    90 days

  • cardiovascular morbidity

    3 months post hospitalisation

  • questionnaire

    3 months post hospitalisation

Study Arms (1)

AKI patients

Patients who suffered from AKI whilst in ICU and are awaiting discharge from hospital

Eligibility Criteria

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

critically ill adult patients in the ICU

You may qualify if:

  • critically ill adult patients who had AKI stage II or III whilst in ICU and are scheduled to be discharged from hospital

You may not qualify if:

  • known pre-existing end-stage kidney disease or advanced CKD (stage 3b or worse)
  • kidney transplant within the last 12 months
  • known primary renal disease
  • discharge from hospital for end-of-life care
  • transfer to another health care institution for ongoing in-patient care
  • not expected to survive for 3 months
  • pregnancy
  • lack of capacity to give consent
  • receiving regular dialysis at hospital discharge
  • CKD stage 3 or worse at hospital discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas Foundation Hospital

London, SE1 7EH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and urine samples

MeSH Terms

Conditions

Acute Kidney InjuryKidney DiseasesRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marlies Ostermann, PhD

    Guy's & St Thomas' NHS Foundation Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 10, 2022

First Posted

February 23, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations