Renji Hospital, Shanghai Jiao Tong University school of medicine
Shanghai, 200001, China
NCT Number: NCT00912821
Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Shanghai, 200001, China
To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation of peritoneal dialysis (PD), we perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6L of dialysate per day and 8L of dialysate per day, follow up will be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical outcomes such as mortality, technique failure, complications and life quality between the two groups will be investigated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6 L peritoneal dialysis solution
8 L peritoneal dialysis solution
Time frame: 2 years
Time frame: 2 years
Shanghai Jiao Tong University School of Medicine
Other
Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07518628
Behavior, Chronic Disease
Nicosia, Cyprus
View Trial DetailsNCT05154773
Chronic Disease, Chronic Kidney Diseases
Buffalo, New York, United States
View Trial DetailsNCT04466865
Behavior, Chronic Disease
Denver, Colorado, United States
View Trial DetailsNCT04395131
Chronic Disease, Disease Attributes
Düsseldorf, Germany
View Trial Details