A competitive acetate-free bicarbonate dialysate and standard bicarbonate dialysate of iron metabolism dysregulation improvement and cytokine production chilling of hemodialysis patients : a cross-over multicenter study.

UMIN ID: UMIN000000773

Registered date:30/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients, who are treated with maintenance hemodialysis more than one year
• Date of first enrollment: 2007/05/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): one year in a 4-month cross-over study. first stage : hemodialysis treatment with standard bicarbonate dialysate. (acetate-containing) second stage: hemodialysis treatment with acetate-free bicarbonate dialysate. (citrate-containing) third stage: hemodialysis treatment with standard bicarbonate. (acetate-containing)

Outcome(s)

• Primary Outcome: (i) dosages of rHuEPO and iron. (ii) improvement of QOL . (iii) iron-related index , inflammation, nutrition, oxidative stress, endthelial injury.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (i) Patients with chronic inflammation (CRP over 0.3), malignant disorder, severe respiratory organs, and liver disorder. (ii) Patients, who are recived dialysis treatment except HD such as HF, HDF, and HDF.

Related Information

• Primary Sponsor: Hyogo College of Medicine
• Source(s) of Monetary Support: Hyogo College of Medicine, Internal Medicine (Nephrology and Dialysis)