| Protocol ID | NCT05415969 |
| Registration Date | 2022-06-13 |
| Status | completed |
| Sponsor | University of Applied Sciences of Western Switzerland |
| Country | Switzerland |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2022-09-01 |
| Last Patient Out | 2023-10-09 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT05415969
Uremic Pruritus Among Adults on Dialysis in the French Speaking Part of Switzerland
| Field |
GLM
glm-5.1 8601ms / 9266 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4867ms / 10626 tok |
OPENAI
gpt-4o Thinking: o3 3029ms / 9083 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | renal | renal | renal | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | N/A | N/A | N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is an observational study focused on identifying prevalence and severity of chronic kidney disease-associated pruritus through measurements and assessments, not providing educational interventions to participants.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial's primary focus is on identifying the prevalence and severity of CKD-aP among dialysis patients, not on providing education as a principal intervention.
|
OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: yes — The trial is an observational study focused on identifying the prevalence and severity of a condition and measuring biomarkers, which fits the residual category as it does not involve pharmacologic, device, or other specified active interventions.
|
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — This is an observational study focused on identifying prevalence and severity of CKD-associated pruritus through questionnaires and biomarker measurements, which does not constitute an active intervention but rather assessment/screening activities.
Thinking: yes — This is an observational assessment study measuring prevalence and biomarkers, not fitting any specified intervention categories.
|
yes
yes → no → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The study is observational and focuses on assessing the prevalence and severity of CKD-aP, which does not involve any intervention fitting exercise, nutritional, or environmental categories.
Thinking: no — The study’s only intervention is assessing/screening patients to identify prevalence and severity of pruritus, which fits the screening category.
|
|
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other |
yes
yes → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The secondary outcomes measure biomarkers (sweat electrolytes and urea) to investigate pathogenesis, which are not covered by symptom, QoL, dignity, or cost categories.
|
yes
yes → no → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — All outcomes measure symptom severity (pruritus) and associated biomarkers, which fall under the symptom category.
Thinking: no — All outcomes measure symptom prevalence/severity (pruritus) or related biomarkers, with no caregiver, communication, survival, or other specified outcomes.
|
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — All outcomes focus on symptoms, specifically the prevalence and severity of pruritus, and do not extend to non-symptom categories.
Thinking: yes — The trial measures laboratory biomarker outcomes (sweat electrolyte levels) that fall outside symptom, QoL, dignity, or cost domains.
|
|
| pharmacologic_sub | N/A | N/A | N/A | OK |