Acute and chronic renal failure
Conditions
Interventions
Experimental group:Hemodialysis Powder
Control group:Hemodialysis Concentrate
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18~80 years old (including cut-off value), gender is not limited; (2) Patients with chronic renal failure who have been on maintenance hemodialysis for more than 3 months; (3) Hemodialysis treatment 3 times a week, not less than 4 hours each time; (4) Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe hypotension (upper extremity arterial blood pressure systolic blood pressure 180mmHg or diastolic blood pressure >120mmHg) during the screening period; (2) Severe anemia (hemoglobin concentration less than 60g/L) during the screening period; (3) Patients with coagulation disorders (platelet count less than 50×109/L), active intracerebral hemorrhage, active gastrointestinal bleeding, or other severe bleeding tendencies during the screening period; (4) Acute and critical patients with severe heart, liver, lung diseases, serious infections or malignant tumors, and those who are judged by the investigator to be unsuitable; (5) Those who have a history of parathyroidectomy in the past; (6) Diabetic patients with poor blood sugar control (random blood glucose> 11.1mmol/L); (7) Pregnant and lactating women; (8) Those who are mentally abnormal or unstable and cannot cooperate during the test; (9) Those who are allergic to the ingredients of this test product or have severe allergies (allergies to two or more substances); (10) Those who have participated in other interventional device clinical trials or participated in drug clinical trials within 5 half-lives of the last drug within 1 month before the start of this trial; (11) Those who are combined with other blood purification treatments during the trial period and affect the dialysis results; (12) Those who are considered inappropriate by the investigator to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dialysis adequacy was judged by detecting the serum ion K , Na , Cl-, Ca2 , HCO3-, and the pH value of blood before and after the conventional hemodialysis pattern.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The decline rate of creatinine before and after dialysis;The decrease rate of blood urea nitrogen or urea before and after dialysis;Blood glucose values before and after dialysis; | — |
Countries
China
Contacts
Public ContactNiansong Wang
Shanghai Sixth People's Hospital
Outcome results
None listed