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

Study information

Study designObservational single-center retrospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeEfficacy
Participant information sheet Not applicable (retrospective study)
Scientific titleProlonged intermittent renal replacement therapy in elderly patients over 90 years old with acute kidney injury post-infection: a retrospective cohort study
Study objectivesProlonged 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) studiedRenal replacement therapy for acute kidney injury after infection in elderly patients
InterventionUsing prolonged intermittent renal replacement therapy (PIRRT), observe patient survival time and explore the correlation between clinical factors and prognosis.
Intervention typeProcedure/Surgery
Primary outcome measureMeasured 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
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/06/2019
Completion date01/05/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit90 Years
Upper age limit150 Years
SexBoth
Target number of participants30
Total final enrolment20
Key inclusion criteria1. Patients over 90 years old
2. Acute kidney injury (AKI) due to infection
3. Received Prolonged Intermittent Renal Replacement Therapy (PIRRT)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/06/2019
Date of final enrolment01/05/2024

Locations

Countries of recruitment

  • China

Study participating centre

China-Japan Friendship Hospital
2 Yinghua East Street, Chaoyang District
Beijing
100029
China

Sponsor information

China-Japan Friendship Hospital
Hospital/treatment centre

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

Phone +86 10 62328941
Email support@nsfc.gov.cn
Website https://www.zryhyy.com.cn/
ROR logo "ROR" https://ror.org/037cjxp13

Funders

Funder type

Government

National Natural Science Foundation of China
Government organisation / National government
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location
China

Results and Publications

Intention to publish date01/09/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request, 88dahongmao88@sina.com

Editorial Notes

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