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The purpose of this study is to assess the feasibility of amino acid infusions in pediatric cardiac surgery patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acid | Experimental | Participants receive amino acids for up to 3 days starting at the time of their cardiac surgery |
|
| Placebo | Placebo Comparator | Participants receive equivalent volume of placebo for up to 3 days starting at the time of their cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acids | Drug | The participants receive a continuous infusion of a balanced mixture of amino acids (Trophamine) in a dose of 2g/kg/day (max 100g/day) starting at the time of cardiac surgery up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Amino acids Related Adverse Events | Baseline, Daily during infusion upto 48 hours after completion of infusion (upto 5 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shina Menon, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| C545824 | amino-acid, glucose, and electrolyte solution |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
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|
| Placebo | Drug | 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 |
|
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004364 | Pharmaceutical Preparations |