Understand the Difference Between Clinical Measured UF and Real UF.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03864120|
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 11, 2019
The importance of ultrafiltration (UF) and fluid status in peritoneal dialysis has been increasingly aware of over the last two decades. There is growing body of observational evidence showing that low UF is related to unfavorable outcome especially in anuric patients. The other side of the problem of UF is excessive fluid removal could volume deplete patients and result in loss of residual renal function and overexposing the membrane to glucose unnecessarily. UF is a double-edged sword. The correct measure of UF is the bottom line of talking about target.
Measuring UF is supposed to be simple and straight forward. The most common way of measuring UF in clinical practice was to weight the effluent bag and minus the manufacture announced fill volume.
Until about 10 years ago, the society first aware that the measurement error in such way is not acceptable. Overfil (the actual volume of dialysate fill in the bag is more than announced) problem was raised from then.
However, there are several other problems around this issue. Firstly, when the product has just been produced overfill is different between manufactory.
Secondly, the overfill volume does change over transportation and storage. But it is not clear how big the change is.
Thirdly, most of the clinics weight the dialysate effluent rather than measure the volume in CAPD, although the specific gravity of dialysate is clearly not going to be 1g/ml.
Taking the fact measuring weight is much easier than measuring volume in CAPD, the question behind is to understand how big the difference is and consequently whether it is acceptable.
All the patients enrolled in the study would be asked to collect all dialysate effluent of the day of their routine peritoneal dialysis adequacy study and bring to the hospital. The exact weight of the bag for PET test (2.5% glucose concentration and dwell time of 4 hour) before and after the dwell and volume measured of the effluent. The dialysate electrolyte, glucose, protein and creatinine level would also be measured.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Understand the Difference Between Clinical Measured Ultrafiltration and Real Ultrafiltration.|
|Estimated Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
- specific gravity of effluent dialysate is different from water (1g/ml) [ Time Frame: For each patient, the outcome would be cross sectional measured at the time the patient does his 6 monthly routine PET test. The data collection time period of the study is 6 month. ]To describe the specific gravity of effluent dialysate, the exact weight and volume of effluent dialysate bags in the standard peritoneal equivalent test (PET, 2.5% glucose concentration, 2L, dwell time 4 hours) dwell would be measured in different patients.
- whether peritoneal membrane characteristics have impact on specific gravity of effluent dialysate [ Time Frame: For each patient, the outcome would be cross sectional measured at the time the patient does his 6 monthly routine PET test. The data collection time period of the study is 6 month. ]the correlation between specific gravity of effluent dialysate and peritoneal membrane characteristics measured by standard PET test (D/P creatinine and 4 hour ultrafiltration) and peritoneal protein leak (measuring plasma total protein concentration and peritoneal protein loss in the standard PET dwell).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864120
|Contact: Zanzhe Yu, MD||58752345 ext firstname.lastname@example.org|
|Principal Investigator:||Zanzhe Yu, MD||RenJi Hospital|