ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 51 for:    Recruiting, Not yet recruiting, Available Studies | "Peritoneal Dialysis"

Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

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: NCT03322410
Recruitment Status : Not yet recruiting
First Posted : October 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.

High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.

To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.

The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.

This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.


Condition or disease Intervention/treatment Phase
Fluid Overload Peritoneal Hyperpermeability Peritoneal Dialysis Chronic Kidney Disease Biological: modified Peritoneal Equilibration test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Experimental: Patients Biological: modified Peritoneal Equilibration test

Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky

  • " High ": D/P creatinine>0,8; D/D0 glucose<0,25
  • " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
  • " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
  • " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.




Primary Outcome Measures :
  1. Hydratation status [ Time Frame: Day 7 ]

    Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)

    • FO < 10th percentile = extracellular dehydration
    • 10th percentile < FO < 90th percentile = extracellular normohydration
    • FO > 90th percentile = extracellular hyperhydration


Secondary Outcome Measures :
  1. Peritoneal permeability [ Time Frame: Day 7 ]

    Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky

    • " High ": D/P creatinine>0,8; D/D0 glucose<0,25
    • " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
    • " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
    • " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.

  2. Hydratation status [ Time Frame: Day 45 ]

    Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)

    • FO < 10th percentile = extracellular dehydration
    • 10th percentile < FO < 90th percentile = extracellular normohydration
    • FO > 90th percentile = extracellular hyperhydration

  3. Peritoneal permeability [ Time Frame: Day 45 ]

    Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky

    • " High ": D/P creatinine>0,8; D/D0 glucose<0,25
    • " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
    • " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
    • " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.

  4. Hydratation status [ Time Frame: Day 365 ]

    Fluid overload (FO) measured with BMC bioimpedance system (Fresenius medical care®)

    • FO < 10th percentile = extracellular dehydration
    • 10th percentile < FO < 90th percentile = extracellular normohydration
    • FO > 90th percentile = extracellular hyperhydration

  5. Peritoneal permeability [ Time Frame: Day 365 ]

    Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky

    • " High ": D/P creatinine>0,8; D/D0 glucose<0,25
    • " High average ": 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
    • " Low average ": 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
    • " Low " : D/P creatinine<0,5 ; D/D0 glucose>0,49.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • End stage chronic kidney disease
  • Ambulatory
  • Starting a peritoneal dialysis in one of the participant centers
  • Accepting the study protocol
  • Age > 18yo

Exclusion criteria:

  • Age <18yo
  • Protected by the law

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): NCT03322410


Contacts
Contact: Fatouma TOURE 0326787638 ext +33 ftoure@chu-reims.fr
Contact: Vincent DUPONT vdupont@vhu-reims.fr

Locations
France
Damien JOLLY Not yet recruiting
Reims, France
Contact: Fatouma TOURE       ftoure@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03322410     History of Changes
Other Study ID Numbers: PA17003
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by CHU de Reims:
Fluid overload
Hydratation statud
Peritoneal hypepermeability
Peritoneal dialysis
Impedancemetry

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency