Improving Nutritional and Clinical Outcomes in Peritoneal Dialysis (PD) Peritonitis: A Randomized Trial of Whey Protein Supplementation
Bibliographic record
Abstract
Background: Hypoalbuminemia and protein-energy wasting complicate up to half of PD patients and predict worse morbidity and mortality during peritonitis. Despite the theoretical benefits of protein repletion, no trials have directly assessed whether targeted supplementation can improve nutritional status and clinical outcomes. Methods: In this open-label, multicenter randomized trial (TCTR20210329002), 171 adult PD patients with peritonitis and serum albumin <3.5 g/dL were randomized 1:1 across nine Thai centers to receive either 30 g/day of oral whey protein isolate for 30 days plus standard nutritional counseling (intervention) or counseling alone (control). The primary outcome was a composite of all-cause mortality, relapse, repeat or refractory peritonitis, and hemodialysis transfer by day 180. Secondary outcomes included change in serum albumin and adverse events. Analyses followed intention-to-treat principles. Time-to-event outcomes were assessed using Cox regression and restricted mean survival time (RMST), and albumin trends were evaluated with linear mixed-effects models. Results: Mean age was 59±15 years; 53% male; 85% on CAPD. Baseline albumin was 2.66±0.52 g/dL. The composite endpoint occurred in 41% of intervention vs. 58% of controls (HR 0.65; 95% CI 0.42–1.01; RMST gain 11.4 days; p=0.03). Refractory peritonitis was reduced in the intervention arm (24% vs. 41%; HR 0.58; 95% CI 0.36–0.92). Between-group albumin differences were +0.23 g/dL at day 7 (p<0.001), +0.31 at day 30 (p<0.001), +0.19 at day 90 (p=0.006), and +0.24 at day 120 (p=0.001)(Figure 1). Gastrointestinal symptoms were the most common adverse event (38% vs. 22%; p=0.11); no serious toxicity was reported. Conclusion: In PD patients with peritonitis and hypoalbuminemia, short-term protein supplementation improved serum albumin and reduced refractory peritonitis and overall complications. This pragmatic, low-cost intervention may support recovery and warrants further study in broader PD populations. Funding: Government Support – Non-U.S.Figure 1. Change in Serum Albumin
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".