In elderly patients over 90 years old with acute kidney injury post-infection, does prolonged intermittent renal replacement therapy improve outcomes compared to standard therapy?

ISRCTN	ISRCTN24896690
DOI	https://doi.org/10.1186/ISRCTN24896690
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	China-Japan Friendship Hospital
Funder	National Natural Science Foundation of China

Submission date: 18/08/2024
Registration date: 19/08/2024
Last edited: 19/08/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study investigates the effectiveness of a specialized treatment called Prolonged Intermittent Renal Replacement Therapy (PIRRT) in elderly patients over 90 years old who develop acute kidney injury (AKI) following an infection. The goal is to understand how well this treatment works in such elderly patients and to identify factors that affect their survival.

Who can participate?
The study was conducted on elderly patients aged 90 and above who developed AKI after an infection and were treated at the China-Japan Friendship Hospital.

What does the study involve?
We collected and analyzed medical data from patients treated with PIRRT over the past five years. The study focuses on their treatment outcomes and the factors that may influence their survival.

What are the possible benefits and risks of participating?
The findings suggest that nearly half of the elderly patients survived for more than 90 days after receiving PIRRT, indicating that this treatment can be effective. However, patients with pre-existing chronic kidney disease, certain complications like low calcium levels, rapid heart rates, or high potassium levels had a poorer prognosis.

Where is the study run from?
China-Japan Friendship Hospital (China)

When is the study starting and how long is it expected to run for?
June 2019 to May 2024

Who is funding the study?
This research is funded by the National Natural Science Foundation (China) (82304363)

Who is the main contact?
Dr Zheng Zhang, 88dahongmao88@sina.com

Contact information

Dr Zheng Zhang
Public, Scientific, Principal investigator

No. 2, Yinghua East Street, Chaoyang District
Beijing
100029
China

ORCID ID	0000-0002-8480-1555
Phone	+86 18811414199
Email	88dahongmao88@sina.com

Study information

Primary study design	Observational
Study design	Observational single-center retrospective cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Prolonged intermittent renal replacement therapy in elderly patients over 90 years old with acute kidney injury post-infection: a retrospective cohort study
Study objectives	Prolonged intermittent renal replacement therapy (PIRRT) improves clinical outcomes compared to standard therapy in elderly patients over 90 with acute kidney injury following infection.
Ethics approval(s)	Approved 27/09/2016, China-japan Friendship Hospital Clinical Research Ethics Committee (2 Yinghua East Street, Chaoyang District, Beijing, 100029, China; +86 10 66937166; zryyec@126.com), ref: S2016-100-01
Health condition(s) or problem(s) studied	Renal replacement therapy for acute kidney injury after infection in elderly patients
Intervention	Using prolonged intermittent renal replacement therapy (PIRRT), observe patient survival time and explore the correlation between clinical factors and prognosis.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Measured using patient records: 1. Age at baseline 2. Gender at baseline 3. Systolic Blood Pressure: Average all measurements taken from baseline over the next 3 days 4. Diastolic Blood Pressure: Average all measurements taken from baseline over the next 3 days 5. Heart Rate: Average all measurements taken from baseline over the next 3 days 6. Creatinine at baseline 7. Estimated Glomerular Filtration Rate at baseline 8. Urea at baseline 9. Sodium at baseline 10. Potassium at baseline 11. Calcium at baseline 12. Phosphorus at baseline 13. B-type Natriuretic Peptide at baseline 14. Hemoglobin at baseline 15. White Blood Cell Count at baseline 16. Neutrophil Count at baseline 17. Lymphocyte Count at baseline 18. Platelet Count at baseline 19. C-Reactive Protein at baseline 20. Procalcitonin at baseline 21. Prothrombin Time at baseline 22. Activated Partial Thromboplastin Time at baseline 23. SOFA Score at baseline 24. APACHE II Score at baseline
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	01/05/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	90 Years
Upper age limit	150 Years
Sex	All
Target sample size at registration	30
Total final enrolment	20
Key inclusion criteria	1. Patients over 90 years old 2. Acute kidney injury (AKI) due to infection 3. Received Prolonged Intermittent Renal Replacement Therapy (PIRRT)
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/2019
Date of final enrolment	01/05/2024

Locations

Countries of recruitment

China

Study participating centre

China-Japan Friendship Hospital

2 Yinghua East Street, Chaoyang District
Beijing
100029
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request, 88dahongmao88@sina.com

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/08/2024: Trial's existence confirmed by China-japan Friendship Hospital Clinical Research Ethics Committee.