Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05721703 |
| Other study ID # |
S2021-263-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 21, 2021 |
| Est. completion date |
December 31, 2029 |
Study information
| Verified date |
February 2023 |
| Source |
Chinese PLA General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Background: Chronic kidney disease (CKD) is one of the most common non-communicable diseases.
The Global Burden of Disease (GBD), which examined multiple diseases in 188 countries from
1990 to 2013, found that the number of CKD patients increased from 318,665,000 to
47,1916,000, representing a 48% increase in prevalence (2.1% annually). Peritoneal dialysis
is an important renal replacement therapy for participants with end-stage renal disease. The
removal of water mainly depends on the high osmotic pressure of dialysate which is called
ultrafiltration, and the loss of ultrafiltration function of peritoneum is called
ultrafiltration failure. Data from the National Blood Purification Case Information System
(CNRDS) show that the rate of conversion from ultrafiltration failure to hemodialysis is
5%-10%, and cardiovascular complications caused by fluid overload, such as malignant
hypertension and heart failure, are the common causes of death. At the end of 2021, dialysis
data in mainland China showed that there were nearly 880,000 patients undergoing dialysis
treatment, of which 14% chose peritoneal dialysis, the average dialysis age of peritoneal
dialysis patients was 50.3 months, the proportion of patients who had been on dialysis for
more than 5 years was 33.9%, and the proportion of patients who had been on dialysis for more
than 10 years was 7.5%. It can be seen that long-term peritoneal dialysis still has a high
shedding rate, and ultrafiltration failure is the key problem of long-term peritoneal
dialysis.
Methods: Investigators gathered participants from Department of Nephrology, PLA General
Hospital, from May 2021 to May 2029. Inclusion Criteria: 1.Clinically diagnosed as chronic
renal insufficiency (CKD 5); 2.Incident PD patients who were newly inserted PD catheter
during the observation period of this study; 3.Prevalent PD patients who inserted PD cather
before initiation of this study, should be admitted as pre-UFF, has taken long-term PD(>5
years) before removing cather during the observation period of this study; 4.Written informed
consent signed by the patient or the authorized client has been obtained. Exclusion Criteria:
1.Acute renal failure; 2.Pregnant or lactating women; 3.Active infection duration; 4.One of
infectious serum markers of HIV, syphilis, hepatitis B and hepatitis C is positive; 5.Any
other conditions that the investigator considers impossible to join this trial. The observed
indices were: (1)Demographic characteristics; (2)Peritoneal equilibration test (PET D/P),
adequacy assessment(Ccr, Kt/V), evaluation of ultrafiltration (urine volume, intake,etc.);
(3)Peritoneal dialysate routine examination, peritoneal dialysate inflammation examination
and other markers and exosome examination; (4)Classification and counting of exfoliated cells
from peritoneal dialysis effluent, and dialysate exfoliated cells primary culture for further
cell biology analysis; (5)Peritoneal histopathology and immunohistochemical analysis and
proteomics and single cell transcriptome analysis; (6)Clinical examinations: Routine blood
test, Uroscopy, Blood biochemistry test, Coagulation function test, Immunoassay, Bone
metabolism test, Thyroid function test, Evaluation of Ascites, etc. For an incident PD
patient,after admission，the peritoneal catheter was inserted, and the data of the initial
peritoneal equilibration test and clinical examinations were collected, and the peritoneal
membrane was sampled for single-cell analysis. After that, the patient was followed up, and
the data of the subsequent peritoneal equilibration test and clinical examinations were
collected until the end point(technique failure) or the study end(8 years). The investigators
collected the peritoneal tissue for single-cell sequencing when participants remove the
catheters(for the technique failure patients). If the catheter is still in use when this
study stop collecting data(8 years), the peritoneal dialysis effluent will substitute for
peritoneal tissue to the morphological and single-cell analysis. For a prevalent patient who
admitted as pre-UFF, investigators collected the final peritoneal equilibration test and
clinical examination data then sample the peritoneal tissue for single-cell sequencing when
removing the cather. SPSS and R were used for statistical analysis. Continuous variables were
expressed as mean ± standard deviation, and discontinuous variables were expressed as
percentage. The independent t-test or chi-square test was used for comparison between the two
data. P<0.05 was statistically significant.
