{"id":"a26947d9-f1be-5a46-b4c0-8911f1629eda","stable_key":"46d15d9e-d3b5-544d-ba01-b785aa3e4f42:b1-trpss-creatinine-null","predicate":"does_not_significantly_change","statement":"TRPSS did not find a statistically significant difference in its primary creatinine trajectory endpoint; the 72-hour estimate was -0.57 mg/dL, 95% CI -1.18 to 0.04.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"48277eec-ac87-516c-89d3-2e739413324e","mechanism_event_label":"The renal-protection trial left an uncertain estimate rather than proving benefit.","subject":{"id":"36b7c3eb-068b-500f-af1c-078829df1ecc","slug":"thiamine","display_name":"Thiamine (vitamin B1)","entity_type_key":"small_molecule"},"object":{"id":"8ea47507-7da2-5faf-90d9-edce54a0f38b","slug":"serum-creatinine-concentration","display_name":"Serum creatinine concentration","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"48277eec-ac87-516c-89d3-2e739413324e","stable_key":"46d15d9e-d3b5-544d-ba01-b785aa3e4f42:b1-trpss-creatinine-null-event","event_type":"observed_intervention","label":"The renal-protection trial left an uncertain estimate rather than proving benefit.","description":"TRPSS did not find a statistically significant difference in its primary creatinine trajectory endpoint; the 72-hour estimate was -0.57 mg/dL, 95% CI -1.18 to 0.04.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"46cde83c-847b-5bf0-abd9-e3555b94d624","slug":"septic-shock-organ-outcomes","display_name":"Organ outcomes during septic shock","entity_type_key":"cellular_process"},"role":"clinical_scope","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"36b7c3eb-068b-500f-af1c-078829df1ecc","slug":"thiamine","display_name":"Thiamine (vitamin B1)","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"8ea47507-7da2-5faf-90d9-edce54a0f38b","slug":"serum-creatinine-concentration","display_name":"Serum creatinine concentration","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"experimental_model","value_text":"88 treated patients with septic shock.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Study-specific exposure described in the model; no regimen inferred beyond the accessed evidence.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"ICU-free days favored thiamine as a secondary outcome; kidney replacement, severe AKI and mortality differences were not significant.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Thiamine research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"thiamine","display_name":"Thiamine (vitamin B1)","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Homo sapiens","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"The renal-protection trial left an uncertain estimate rather than proving benefit.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[b1-trpss2023] Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial (2023). https://pubmed.ncbi.nlm.nih.gov/37364280/ DOI: 10.1164/rccm.202301-0034oc","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Serum/clinical kidney endpoints","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"d6f604ed-115a-5649-9f88-942c4037d0ce","evidence_kind":"source_excerpt","locator":"Lines 1660-1670","start_line":1660,"end_line":1670,"excerpt":"### b1-trpss-creatinine-null\nTRPSS did not find a statistically significant difference in its primary creatinine trajectory endpoint; the 72-hour estimate was -0.57 mg/dL, 95% CI -1.18 to 0.04.\nCondition category: normal\nnutrient_topic: Thiamine research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: The renal-protection trial left an uncertain estimate rather than proving benefit.\norganism: Homo sapiens\ntissue_or_cell_type: Serum/clinical kidney endpoints\nexperimental_model: 88 treated patients with septic shock.\nlimitations: ICU-free days favored thiamine as a secondary outcome; kidney replacement, severe AKI and mortality differences were not significant.\nexposure: Study-specific exposure described in the model; no regimen inferred beyond the accessed evidence.\n[b1-trpss2023] Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial (2023). https://pubmed.ncbi.nlm.nih.gov/37364280/ DOI: 10.1164/rccm.202301-0034oc","model_system":"88 treated patients with septic shock.","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [b1-trpss2023] Thiamine for Renal Protection in Septic Shock (TRPSS): A Randomized, Placebo-controlled, Clinical Trial (2023). https://pubmed.ncbi.nlm.nih.gov/37364280/ DOI: 10.1164/rccm.202301-0034oc","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"158d2c03-ac8c-589f-8270-c468165ae346","stable_key":"import-46d15d9e-d3b5-544d-ba01-b785aa3e4f42","title":"Thiamine: mechanisms, deficiency and nutrient interactions (2026-09-17)","document_type":"imported_text","citation_label":"AI-assisted literature curation; primary study URLs and scope retained in the document and extraction. Not publisher full text.","file_path":"","sha256":"f376512fb3310141315548015b387833e3af45146e73fb73cd02cee20e4ddb9c","revision_id":"53bc5eda-dec8-58cc-a56f-a9eb4ab036ef","review_status":"unverified_draft","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}