Acute Kidney InjuryNCT05740709
Identification of Patients at Risk of CKD After AKI
An observational study of Acute Kidney Injury and Kidney Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Kidney Diseases
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill adult patients in the ICU
Who may be able to join
- critically ill adult patients who had AKI stage II or III whilst in ICU and are scheduled to be discharged from hospital
Who cannot join
- 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
Show all 10Show fewer
- pregnancy
- lack of capacity to give consent
- receiving regular dialysis at hospital discharge
- CKD stage 3 or worse at hospital discharge
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's & St Thomas Foundation Hospital
London, SE1 7EH
Marlies Ostermann, 02071887188 ext. 83038, Marlies.Ostermann@gstt.nhs.uk
About this study
Official title: Identification of Patients at Risk of Chronic Kidney Disease After Acute Kidney Injury
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.
Read the detailed description
Acute kidney injury (AKI) is a common complication during critical illness and associated with serious short and long-term complications. Participants with AKI have an increased risk of developing dysfunction of other organs, including multi-organ failure, a longer stay in hospital and a higher risk of dying. Survivors remain at risk of complications, even if kidney function initially recovers. In particular, they are at high risk of developing chronic kidney disease, dialysis-dependent end-stage kidney disease and cardiovascular comorbidities. At present, the tools to identify patients at highest risk of chronic kidney disease (CKD) are very limited.
The investigators will recruit participants who had AKI whilst in ICU and are scheduled to be discharged from hospital. Within 3 days of discharge from hospital, blood and urine kidney biomarkers will be measured to explore whether there is a correlation with renal function 3 months later and to identify those at highest risk of CKD. In addition, quality of life at 3 months will be assessed.
- Conditions
- Acute Kidney Injury, Kidney Diseases
- Keywords
- acute kidney injury, chronic kidney disease, kidney biomarkers
- Medical subject headings
- Acute Kidney Injury, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AKI patients | Patients who suffered from AKI whilst in ICU and are awaiting discharge from hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine
estimated glomerular filtration rate (eGFR) <60ml/min
Measured: 3 months after discharge from hospital
Secondary outcomes (3)
mortality
mortality
Measured: 90 days
cardiovascular morbidity
new or worsened cardiovascular morbidity
Measured: 3 months post hospitalisation
questionnaire
health-related quality of life based on questionnaire EQ-5D-5L
Measured: 3 months post hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlies Ostermann, PhD, Principal investigator, Guy's & St Thomas' NHS Foundation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740709
- Sponsor's protocol ID
- IRAS 319992
- Status last verified
- Jan 2024
- First submitted
- 10 Oct 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Patients at Risk of Chronic Kidney Disease After Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05740709
- Acronym / sponsor ID
- IRAS 319992
- Conditions
- Acute Kidney Injury, Kidney Diseases
- Keywords
- acute kidney injury, chronic kidney disease, kidney biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute kidney injury (AKI) is a common complication during critical illness and associated with serious short and long-term complications. Participants with AKI have an increased risk of developing dysfunction of other organs, including multi-organ failure, a longer stay in hospital and a higher risk of dying. Survivors remain at risk of complications, even if kidney function initially recovers. In particular, they are at high risk of developing chronic kidney disease, dialysis-dependent end-stage kidney disease and cardiovascular comorbidities. At present, the tools to identify patients at highest risk of chronic kidney disease (CKD) are very limited.
The investigators will recruit participants who had AKI whilst in ICU and are scheduled to be discharged from hospital. Within 3 days of discharge from hospital, blood and urine kidney biomarkers will be measured to explore whether there is a correlation with renal function 3 months later and to identify those at highest risk of CKD. In addition, quality of life at 3 months will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKI patients | – | –Patients who suffered from AKI whilst in ICU and are awaiting discharge from hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill adult patients in the ICU
Key inclusion criteria (1 listed)
- critically ill adult patients who had AKI stage II or III whilst in ICU and are scheduled to be discharged from hospital
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
serum creatinine
Time frame: 3 months after discharge from hospital
estimated glomerular filtration rate (eGFR) <60ml/min
3 secondary outcomes
mortality
Time frame: 90 days
cardiovascular morbidity
Time frame: 3 months post hospitalisation
questionnaire
Time frame: 3 months post hospitalisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies Ostermann, PhD principal investigator
Guy's & St Thomas' NHS Foundation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Kidney Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlies Ostermann, PhD (02071887188 ext. 83035, Marlies.Ostermann@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine (time frame: 3 months after discharge from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.