An Observational Study of Long-term Peritoneal Dialysis Patients Who Eventually Develop Ultrafiltration Failure (LUFF)

NCT05721703 | Active Not Recruiting DMC

• 1 other identifier: S2021-263-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

At present, there are few researches on peritoneal dialysis, especially on ultrafiltration failure of peritoneal dialysis. To explore the regularity and mechanism of peritoneal ultrafiltration failure,investigators followed up the comprehensive data of participants from the insertion to the removal of the peritoneal dialysis catheter, and collected the peritoneal tissue for morphological and single-cell analysis when the participants inserting or removing their catheters. If the catheter is still in use when this study stop collecting data, the peritoneal dialysis effluent will substitute for peritoneal tissue to the morphological and single-cell analysis. Clinical data and single-cell sequence data were processed using statistical analyses to identify factors affecting ultrafiltration failure.

Conditions

Ultrafiltration Failure

Keywords

peritoneal dialysis; Ultrafiltration Failure; long-term

Outcome Measures

Primary Outcomes (1)

• Technical survival rate

  Technical survival of peritoneal dialysis

  8 year

Secondary Outcomes (10)

• D/P

  1,2,3,4,5,6,7,8 year

• OCG

  1,2,3,4,5,6,7,8 year

• Ccr

  1,2,3,4,5,6,7,8 year

• Kt/V

  1,2,3,4,5,6,7,8 year

• Cell counting

  1,2,3,4,5,6,7,8 year

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who were diagnosed CKD5 age 18 to 70 need or keep peritoneal dialysis to treat or someone was ultrafiltration failure without AKI, pregnant or lactating women, active infection, infectious diseases and be asked to sign an "informed consent form".

You may qualify if:

• Clinically diagnosed as chronic renal insufficiency (CKD 5)
• Patients who met the first dialysis guidelines for peritoneal dialysis without catheter, or patients with peritoneal dialysis regularly, or ultrafiltration failure was diagnosed and patients on peritoneal dialysis were to be existed.
• Written informed consent signed by the patient or the authorized client has been obtained.

You may not qualify if:

• Acute renal failure.
• Pregnant or lactating women.
• Active infection duration.
• One of infectious serum markers of HIV, syphilis, hepatitis B and hepatitis C is positive.
• Any other conditions that the investigator considers impossible to join this trial.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, dialysate, etc.

Study Officials

• CHEN Xiangmei, yes

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Blood purification Branch, Division of Nephrology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: February 10, 2023
• Study Start: May 21, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CN (1)