Szeto 2003.
Methods | Country: Hong Kong Setting/Design: University, randomised trial Time frame: 12 months Randomisation method: not stated Blinding ‐ Participants: Yes ‐ Investigators: Yes ‐ Outcome assessors: Yes ‐ Data analysis: Yes Intention‐to‐treat: Yes Loss to follow‐up: 4/30 and 3/30 in intervention and control respectively | |
Participants | INCLUSION CRITERIA
Plasma bicarbonate level measured twice in the 3 months prior to enrolment.
Total weekly Kt/V < 2.1
Venous bicarbonate ≤ 25 mmol/L on 2 consecutive measurements
Stable clinical condition and CAPD regimen for at least 12 months TREATMENT GROUP Number: 30 Age: 54.3 ± 12.4 years Sex (M/F): 16/14 Duration of dialysis: 39.9 ± 20.8 months Diabetes: 12 CONTROL GROUP Number: 30 Age: 56.6 ± 13.2 years Sex (M/F): 19/11 Duration of dialysis: 39.4 ± 26.0 months Diabetes: 8 EXCLUSIONS Patients unlikely to survive, planned living‐related kidney transplant, transfer to other renal centre within 6 months |
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Interventions | TREATMENT GROUP
Oral sodium bicarbonate 0.9 g thrice daily CONTROL GROUP Placebo (pure starch tablet) CO‐INTERVENTIONS None stated |
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Outcomes | Total Kt/V Residual GFR Subjective global assessment of nutrition (SGA) Normalised protein nitrogen appearance (NPNA) Anthropometric lean body mass (LBM) Anthropmetric measures (e.g. biceps skinfold thickness) Oedema, weight, hospitalisation, technique failure, mortality | |
Notes | Appearance, packaging and labeling of tablets were identical | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |
iPTH ‐ immunoactive parathormone