[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07001098":3,"trial-entities:NCT07001098":80,"trial-summary:NCT07001098":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":15,"eligibility_criteria":52,"std_ages":60,"locations":63,"central_contacts":73,"overall_officials":74,"references":78,"see_also_links":79},"NCT07001098","80133","Amino Acids for Cardiac Surgery Associated AKI","Amino Acids for the Infant at Risk for Acute Kidney Injury After Cardiac Surgery: A Pilot Study","NOT_YET_RECRUITING","2026-11","2025-05","2025-06-03","2025-09","Stanford University","OTHER",false,"The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.",null,[19],"Acute Kidney Injury",[21],"cardiac surgery","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},30,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Amino Acids","The participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g\u002Fkg\u002Fday (max 100g\u002Fday) starting at the time of cardiac surgery up to 3 days",[35],"Amino acid",[37],"AA, Trophamine",{"type":31,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Placebo","The participants receive a continuous infusion of a lactated ringers (placebo), equivalent volume to amino acids, starting at the time of cardiac surgery up to 3 days",[39],[43],"Lactated Ringer",[45],{"measure":46,"timeFrame":47},"Number of Participants with Amino acids Related Adverse Events","Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days)",[],"ALL","1 Day","18 Years",{"inclusion":53,"exclusion":55,"raw_text":59},[54],"Undergoing cardiac surgery and expected to be high risk",[56,57,58],"preoperative extracorporeal organ support","CKD history (GFR\\\u003C60ml\u002Fmin\u002F1.73m2 \\[≤1year\\] and GFR\\\u003C90ml\u002Fmin\u002F1.73m2 \\[\\>1 year\\])","serum creatinine defined preoperative AKI.","Inclusion Criteria:\n\n* Undergoing cardiac surgery and expected to be high risk\n\nExclusion Criteria:\n\n* preoperative extracorporeal organ support\n* CKD history (GFR\\\u003C60ml\u002Fmin\u002F1.73m2 \\[≤1year\\] and GFR\\\u003C90ml\u002Fmin\u002F1.73m2 \\[\\>1 year\\])\n* serum creatinine defined preoperative AKI.",[61,62],"CHILD","ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"Lucile Packard Children's Hospital","Palo Alto","California","94305","United States",{"lat":71,"lon":72},37.44188,-122.14302,[],[75],{"name":76,"affiliation":13,"role":77},"Shina Menon, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":81,"biomarkers":84},[82,83],"Acute Renal Failure","Cardiac Surgery",[],{"nct_id":4,"found":86,"summary":87,"prompt_version":95},true,{"design":88,"status":89,"heading":6,"summary":90,"follow_up":88,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"Not specified.","completed","{\n   \"Amino Acids for Pediatric Cardiac Surgery AKI\",\n   \"This study is looking at whether giving amino acids (Trophamine) to children undergoing heart surgery is safe and practical. Some participants will receive a continuous infusion of Trophamine, while others will receive a placebo (lactated ringers solution). The main goal is to see how many participants experience side effects related to the amino acid infusion. This study is for children aged 1 day to 18 years who are having heart surgery and are at high risk for acute kidney injury (AKI). You cannot join if you have certain pre-existing kidney conditions or are already on life support. The study plans to enroll 30 participants, but its current recruitment status is unclear.\",\n  \"design\": \"This is an interventional study comparing amino acids to a placebo in about 30 participants. It is not specified if participants or researchers will know which treatment is being given.\",\n  \"commitments\": \"Participants will receive a continuous infusion of either amino acids or placebo starting at the time of cardiac surgery and continuing for up to 3 days. Adverse events will be monitored daily during the infusion and for up to 48 hours after it stops (up to 5 days total).\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be monitored for adverse events for up to 5 days after the infusion begins.\",\n}",225,"Not specified in the trial record.","Not stated in the trial record.",[32,39],"v2"]