- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02168283
Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease patients. However, cardiovascular disease remains the major cause of morbidity and mortality in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an important cause of cardiovascular disease in PD patients.
OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood pressure, hospitalization and cardiovascular morbidity in PD patients.
HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could improve the clinical outcome of PD patients.
DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters. Patients will be randomized to active fluid management (treatment arm) or conventional management (control arm).
STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.
INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling, diuretics, and intensive dialysis regimen. For the control arm, patients will only receive dietary counseling. Patients will be followed for one year.
MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of hospitalization for all cause, and hospitalization for cardiovascular disease during the study period.
DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization data will be compared by non-parametric Mann Whitney U test.
EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload in PD patients.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
-
Shatin, Hong Kong
- Prince of Wales Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy
Exclusion Criteria:
- clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion)
- overt pulmonary edema and required urgent medical care
- cognitive impairment or problem of communication
- unlikely to survive for more than three months
- mechanical problems of the dialysis catheter
- active peritonitis or peritoneal failure
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: treatment arm
active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
|
Hypertonic peritoneal dialysis cycles
Dietary counseling
|
|
Aktiv komparator: control arm
dietary counseling alone
|
Dietary counseling
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
blood pressure control
Tidsramme: 1 year
|
1 year
|
|
number of antihypertensive medications
Tidsramme: 1 year
|
1 year
|
|
duration of hospitalization for all cause
Tidsramme: 1 year
|
1 year
|
|
hospitalization for cardiovascular disease
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
dødelighed af alle årsager
Tidsramme: 1 år
|
1 år
|
|
degree of overhydration
Tidsramme: 1 year
|
1 year
|
|
change in residual GFR
Tidsramme: 1 year
|
1 year
|
|
nutritional status
Tidsramme: 1 year
|
1 year
|
|
arterial pulse wave velocity
Tidsramme: 1 year
|
1 year
|
|
cardiovascular mortality
Tidsramme: 1 year
|
1 year
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
cause of hospital admission
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BPBCM
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