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

NCT02488200 | Unknown

• 1 other identifier: CRU ID 15002474
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who start planned dialysis initiation as defined by the protocol

  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.

  1 year

Secondary Outcomes (3)

• Death

  1 year

• Choice of dialysis modality

  1 year

• Choice of dialysis access

  1 year

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 1 Month - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Kidney Disease Stage 5 WHO start dialysis therapy for ESRD

You may qualify if:

• All patients starting maintenance dialysis therapies at the participating centers

You may not qualify if:

• Africans

Sponsors & Collaborators

• Herlev Hospital: lead
• Odense University Hospital: collaborator
• Aarhus University Hospital Skejby: collaborator
• Zealand University Hospital: collaborator
• Holbaek Sygehus: collaborator
• Central Jutland Regional Hospital: collaborator
• Sonderborg Hospital: collaborator
• Skovde Hospital: collaborator
• Karolinska University Hospital: collaborator
• Lund University Hospital: collaborator
• Turku University Hospital: collaborator
• Pauls Stradins Clinical University Hospital: collaborator
• Tartu University Hospital: collaborator
• The Hospital of Vestfold: collaborator
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James G Heaf, MD DMSc

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James G Heaf, MD DMSc

CONTACT

+4535125361; heaf@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: July 2, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)