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| Name | Class |
|---|---|
| Congenital Heart Alliance of Cincinnati | UNKNOWN |
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The goal of the BRAVE-HEART study is to learn if an amino acid infusion can reduce the risk of developing acute kidney injury after cardiac surgery in children. The main questions it aims to answer are:
Researchers will compare amino acids to a placebo (a look-alike substance that contains no drug) to see if amino acids decrease the number of participants with acute kidney injury.
Participants will receive an amino acid or placebo infusion for up to 72 hours starting during cardiac surgery and only while in the operating room or the intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acid Acid Infusion | Experimental | Amino Acid Infusion for up to 72 hours |
|
| Placebo Infusion | Placebo Comparator | Placebo Infusion for up to 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acid infusion | Drug | Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute kidney injury on post-operative days 2, 3, or 4 | The rate of participants randomized to the amino acid infusion developing acute kidney injury as defined by Kidney Disease Improving Global Outcomes (KDIGO) as Stage 1, 2, or 3 will be compared to the rate of acute kidney injury in the placebo group | From enrollment to post-operative day 4 |
| Rate of mechanical ventilation at 96 hours post-operatively | Rate of participants randomized to the amino acid infusion needing invasive mechanical ventilation beyond 96 hours post-operatively from congenital cardiac surgery repair will be compared to the rate from the placebo group. | From enrollment to 96 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelli Krallman, RN, BSN, MS | Contact | 513-636-4837 | kelli.krallman@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Stuart Goldstein, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
With a small data set from a single center, there is a high risk of the participants being able to be re-identified with the details within the data set.
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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 |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Lactated ringers solution | Drug | Placebo infusion to match the volume of the amino acid infusion in grams/kilogram/day |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |