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Peridialysis Project: The Influence of Predialysis Factors on the Initial Course of Dialysis (Peridialysis)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02488200
Recruitment Status : Unknown
Verified February 2018 by James heaf, Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : July 2, 2015
Last Update Posted : February 26, 2018
Sponsor:
Collaborators:
Odense University Hospital
Aarhus University Hospital Skejby
Zealand University Hospital
Holbaek Sygehus
Central Jutland Regional Hospital
Sonderborg Hospital
Skovde Hospital
Karolinska University Hospital
Lund University Hospital
Turku University Hospital
Pauls Stradins Clinical University Hospital
Tartu University Hospital
The Hospital of Vestfold
St. Olavs Hospital
Oslo University Hospital
Information provided by (Responsible Party):
James heaf, Herlev Hospital

Brief Summary:

The present study plans to delineate the clinical, biochemical, sociological and psychological factors. involved in dialysis preparation, and their impact on dialysis initiation (DI), modality choice and prognosis. In particular the following questions are to be answered.

  1. What factors influence unplanned DI?
  2. What factors influence choice of dialysis modality?
  3. What factors influence choice of dialysis access?
  4. Why do physicians start dialysis?
  5. What factors in the predialytic period and its immediate aftermath (the "peridialytic" period) influence prognosis?

Condition or disease Intervention/treatment
End Stage Renal Disease Other: No intervention

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Peridialysis Project: The Influence of Predialysis Factors on the Initial Course of Dialysis
Study Start Date : January 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Proportion of patients who start planned dialysis initiation as defined by the protocol [ Time Frame: 1 year ]

    Planned dialysis

    The patient's first dialysis is planned if:

    1. His first hemodialysis uses an AV fistula
    2. His first hemodialysis uses a permanent catheter as the patient's permanent access
    3. His first peritoneal dialysis is >6 days after catheter placement.

    The patient's first dialysis is unplanned if:

    1. His first hemodialysis uses a temporary catheter
    2. His first hemodialysis uses a permanent catheter as the patient's temporary access (i.e. a later AV fistula is planned.
    3. His first peritoneal dialysis is <7 days after catheter placement.


Secondary Outcome Measures :
  1. Death [ Time Frame: 1 year ]
    Time to patient death

  2. Choice of dialysis modality [ Time Frame: 1 year ]
    Centre HD, Home HD, CAPD or APD

  3. Choice of dialysis access [ Time Frame: 1 year ]
    AVF, AVG, Temporary CVC, Tunneled CVC, or PD catheter



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Chronic Kidney Disease Stage 5 WHO start dialysis therapy for ESRD
Criteria

Inclusion Criteria:

  • All patients starting maintenance dialysis therapies at the participating centers

Exclusion Criteria:

  • Africans

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): NCT02488200


Contacts
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Contact: James G Heaf, MD DMSc +4535125361 heaf@dadlnet.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: James G Heaf, MD DMSc    +4535125361    heaf@dadlnet.dk   
Sponsors and Collaborators
Herlev Hospital
Odense University Hospital
Aarhus University Hospital Skejby
Zealand University Hospital
Holbaek Sygehus
Central Jutland Regional Hospital
Sonderborg Hospital
Skovde Hospital
Karolinska University Hospital
Lund University Hospital
Turku University Hospital
Pauls Stradins Clinical University Hospital
Tartu University Hospital
The Hospital of Vestfold
St. Olavs Hospital
Oslo University Hospital
Investigators
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Principal Investigator: James G Heaf, MD DMSc Herlev Hospital

Additional Information:

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Responsible Party: James heaf, Doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02488200    
Other Study ID Numbers: CRU ID 15002474
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency