Background
Methods
Study design
Main inclusion criteria
Main exclusion criteria
Trial intervention and visit schedule
Randomization
Blinding
Pre-inclusion visit
Gender | serum creatinine (Scr) | CKD-EPI formula |
---|---|---|
female | ≤0.7 mg/dL | eGFR = 144 × (Scr/0.7)-0.329X(0.993)age |
Scr > 0.7 mg/dL | eGFR = 144 × (Scr/0.7)-1.209X(0.993)age | |
male | Scr ≤0.9 mg/dL | eGFR = 141 × (Scr /0.9)-0.411X(0.993)age |
Scr > 0.9 mg/dL | eGFR = 141 × (Scr /0.9)-1.209X(0.993)age |
Inclusion visit
Intervention
Routine dialysis initiation group
Clinical score of symptoms of hypervolemia | |
---|---|
Systolic Blood pressure ≥ 180 (new onset) | + 2 |
Pretibial edema, weak | + 2 |
Chronic coughing (new) | + 2 |
Dyspnoea at rest, recumbent | + 2 |
Pretibial edema, severe | + 3 |
Dyspnoea at rest, one cushion | + 3 |
Dyspnoea at rest, two cushions | + 4 |
Dyspnoea at rest, sitting | + 6 |
Patients meet any of the following conditions may begin emergency dialysis after adequate drug therapy: | |
---|---|
(1)oliguria or anuria for more than 2 days | |
(2)hyperkalemia: blood potassium > 6.5 mmol/L | |
(3)carbon dioxide combining power (CO2CP) < 13 mmol /L | |
(4)acute pulmonary edema | |
(5)Gallop rhythm of the heart |
Deferred Dialysis initiation group
Follow-up
Parameters recorded | Pre-inclusion visit | inclusion visit | Before dialysis | Initiation dialysis | After dialysis | ||
---|---|---|---|---|---|---|---|
Quarterly visit | every 6 months visit | Quarterly visit | every 6 months visit | ||||
Medical history | X | ||||||
Symptoms | X | X | X | X | X | ||
Physical evaluation | X | X | X | X | X | ||
SGA | X | X | X | X | |||
QOL | X | X | X | X | |||
CBC | X | X | X | X | |||
Alb | X | X | X | X | |||
Scr | X | X | X | X | X | ||
eGFR | X | X | X | X | X | ||
SI and Ferritin | X | X | X | X | |||
iPTH | X | X | X | X | |||
BNP | X | X | X | X | |||
CRP | X | X | X | X | |||
DW | X | X | |||||
UF | X | X | |||||
UO | X | X | |||||
Clinical events | X | X | X | ||||
Costs | X | X | X |
Endpoints
Primary endpoint
Secondary endpoints
- Assess the hospitalization rates by comparing proportion of patients who are admitted to hospital before and after dialysis treatment between the two groups;
- Assess the nutritional status before and after dialysis treatment between the two groups by using SGA assessment and serum albumin levels;
- Assess patient reported quality of life by using SF-36.
- Assess the complications of dialysis after dialysis treatment between the two groups;
- Implement a cost study.•Assess arteriovenous fistulas rate and catheter usage as blood access at first dialysis.