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Outcome Measures

Primary Outcomes (1)

Comparison of the incidence of a composite endpoint for technique failure and death
Technique failure is defined as: * Treatment transferred from PD to HD/PHD \> 30 days; or * PHD, defined as adding HD treatment at least once every 2 weeks in 30 days during PD and requiring long-term combined HD as determined by the investigator. Death is specified as deaths during PD or deaths within 30 days with treatment from PD to HD/PHD
12 months

Secondary Outcomes (6)

Comparison of the proportion of patients with technique failure
12 months
Comparison of the incidence of cardiovascular events
12 months
Comparison of the incidence of the changes in ejection fraction
12 months
Comparison of all-cause deaths
12 months
Comparison of medical resource utilization in terms of hospitalizations
12 months
+1 more secondary outcomes

Study Arms (2)

Icodextrin (ICO) Group

Icodextrin is only intended for intraperitoneal administration and is recommended for long dwell during CAPD (i.e., recommended dwell time from 8-16 hours). Administration will be done at a rate that is comfortable for the patient, typically within 10-20 minutes.

Drug: Icodextrin Peritoneal Dialysis Solution

Glucose Group

During CAPD, 2L of dialysis fluid is instilled into the peritoneal cavity and allowed to dwell for a certain period. The dwell time typically ranges from 4 to 8 hours during the day and 8 to 12 hours at night. This process is repeated 3 to 4 times a day, for 6 to 7 days a week. The frequency of solution exchanges may vary for each individual to achieve desired biochemical and solution control. Most solution exchanges utilize a 1.5% or 2.5% glucose dialysis solution. If more solution removal is required, a 4.25% glucose peritoneal dialysis solution can be used. Regular measurement of the patient's weight can be used to guide the setting of ultrafiltration volume.

Drug: Glucose Peritoneal Dialysis Solution

Interventions

Icodextrin Peritoneal Dialysis SolutionDrug

The treatment modality, treatment frequency, treatment dose, duration of dwell, and length of treatment, as determined and supervised by a prescribing physician experienced in treating ESRD with PD.

Also known as: Extraneal

Icodextrin (ICO) Group

Glucose Peritoneal Dialysis SolutionDrug

The treatment modality, number of daily dialysate exchanges, dialysate concentration, exchange dosage of dialysate, duration of dwell, and length of treatment for PD patients as determined by the clinician.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients in China prescribed icodextrin or glucose PD solutions for continuous ambulatory peritoneal dialysis.

You may qualify if:

Age ≥ 18 years old at first prescription of icodextrin, male or female;

Study Sites (10)

Beijing Haidian Hospital

Beijing, 100000, China

Hangzhou Hospital Of Traditional Chinese Medicine

Hangzhou, 310007, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, 010000, China

Nanjing Drum Tower Hospital

Jiangse, 210008, China

Wuxi People's Hospital

Jiangse, 214023, China

The First People's Hospital of Kunshan

Jiangse, 215300, China

Ningbo First Hospital

Ningbo, 315000, China

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Icodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Icodextrin (ICO) Group

Glucose Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Icodextrin (ICO) Group

Glucose Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations