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Understand the Difference Between Clinical Measured UF and Real UF.

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ClinicalTrials.gov Identifier: NCT03864120
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zanzhe Yu, RenJi Hospital

Brief Summary:

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
Peritoneal Dialysis

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult (>18years), both gender, end stage renal disease on PD treatment
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. on PD treatment for at least one month
  3. signed the consent

Exclusion Criteria:

  1. Peritonitis or recovery from peritonitis for less than one month.
  2. On any intra peritoneal treatment apart from peritoneal dialysis.
  3. Evidence of decompensated liver cirrhosis or heart failure.
  4. Evidence of extra peritoneal leakage, eg. leakage to thoracic cavity, post peritoneal, hernia.

Information from the National Library of Medicine

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


Contacts
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Contact: Zanzhe Yu, MD 58752345 ext 33364 yuzzhrsd@163.com

Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Zanzhe Yu, MD RenJi Hospital

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Responsible Party: Zanzhe Yu, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier: NCT03864120     History of Changes
Other Study ID Numbers: 仁济2018(078)
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No