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A Research Proposal to Set up an Integrated National Data Bank and Monitoring System and to Establish the Indicators and Risk Factors for Chronic Kidney Disease

11. oktober 2011 oppdatert av: Yung-Ho Hsu, Taipei Medical University WanFang Hospital
This project expects the integrated database of terminally renal ill patients combines clinical and files of Health Insurance and renal medical society database. It will provide valuable actual evidence data to quality monitoring of dialysis treatment and related academic research. Besides, using the cohort study of chronic renal disease --「epidemiologic research of chronic renal disease」, we can trace the patient continually and analysis different risk factors of chronic renal disease in Taiwan. Taken together, the results of this project --1.1「Integrate the current database of renal disease and establishment of national monitor system」and 1.2「Epidemiologic study in chronic renal disease」-- will provide the basic rules of prevention and treatment, basic research and clinic application in chronic renal disease.

Studieoversikt

Status

Ukjent

Detaljert beskrivelse

The main source of patient in this study sub-plan 1.2 will collect the patient from medical center in Taiwan. We assume collect 7 groups in study period -- First:【CKD stage I】. Second:【CKD stage II】. Third:【CKD stage III】. Forth:【CKD stage IV】. Fifth:【CKD stage V】. Sixth:【CKD high-risk group】. Seventh:【health control group】to study case report;Total collect 11500 people. At the same time, we collect the sample of blood and urine and personal health survey to provide the basic data base for each patient.

Studietype

Observasjonsmessig

Registrering (Forventet)

700

Kontakter og plasseringer

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Studiesteder

      • Taipei, Taiwan
        • Taipei Medical University - Shuang-Ho Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

chronic kidney disease patients

Beskrivelse

Inclusion Criteria:

  1. Collection of CKD patient group: The patients who will select into this plan are chosen from the hospital (This hospital is defined as the renal disease improving institute) in Taiwan. New case in this hospital will be collected into the CKD patient group. In order to separate those patients into five stages of CKD, we are going to calculate the glomerular filtration rate (GFR) by using the formula of GFR. Stage I -- Renal function is normally and protein was detectable slightly in urine (GFR:≧90ml/min/1.73M2). Stage II -- Slight renal function failure was observed (GFR:60~89ml/min/1.73M2). Stage III -- Moderate renal function failure (GFR:30~59ml/min/1.73M2). Stage IV -- Severe renal function failure (GFR:15~29ml/min/1.73M2). Stage V -- End stage renal disease (GFR:<15ml/min/1.73M2). The age is from fourteen to eighty-five and whatever they are male or female will be taken into this project.
  2. Collection of CKD high-risk group: The CKD patient's relative will be considerately incorporated into the CKD high-risk group. If CKD patient being confirmed, their relative who had chronic disease including DM, hypertension and CVD will be chosen into CKD high-risk group. The age is from fourteen to eighty-five and whatever they are male or female. This plan will select five thousand people into CKD high-risk group.
  3. Collection of healthy control group: According to the characteristic of CKD patient group, we will select the health control group carefully (paired selection of CKD patient group, 1:1). The rules of paired selection : 1. Sex 2.Age ± 5 years 3.Location -- CKD patient and health people are get from the same hospital. Health people who had no any chronic disease and required a physical checkup which get from the hospital (This hospital should be qualified to the renal disease improving institute) will be chosen into this project. Fifteen hundred people will be taken in this plan.

Exclusion Criteria:

  • This plan divide into three groups:1. CKD patient group -- CKD patient group have no exclusion criteria. 2. CKD high-risk group -- CKD high-risk group exclude the patient who had renal disease. 3. Heath control group -- Heath control group exclude the patient who had any chronic disease. Test of liver residual function will exclude the patient who had allergic reactions to galactose. It will exclude the person including galactosemia patient, DM patient, pregnant woman, children and disabled people.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Kohorter og intervensjoner

Gruppe / Kohort
Collection of CKD patient group
Collection of CKD high-risk group
Collection of healthy control group

Samarbeidspartnere og etterforskere

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Etterforskere

  • Hovedetterforsker: Yung-Ho Hsu, Taipei Medical University Shuang Ho Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2011

Studiet fullført (Forventet)

1. mai 2014

Datoer for studieregistrering

Først innsendt

11. oktober 2011

Først innsendt som oppfylte QC-kriteriene

11. oktober 2011

Først lagt ut (Anslag)

14. oktober 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. oktober 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. oktober 2011

Sist bekreftet

1. oktober 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 100009

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