A Phase 2 interventional study of Amino Acid infusion and Lactated Ringer Solution in Acute Kidney Injury, sponsored by Children's Hospital Medical Center, Cincinnati. Not yet recruiting. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 2, Interventional, and Prevention
The goal of this clinical trial is to learn whether giving amino acids through an IV during and after heart surgery can protect the kidneys of children with congenital heart disease. Many children who have heart surgery using a heart-lung (bypass) machine develop a sudden decrease in kidney function, called acute kidney injury (AKI). AKI can lead to a longer hospital stay and other complications, and over time it may raise the risk of long-term kidney disease. Children with congenital heart disease often need more than one heart surgery, so their kidneys may face this risk several times. There is currently no treatment proven to prevent AKI in children after heart surgery. Amino acids are the building blocks of protein. Giving amino acids through an IV increases blood flow and oxygen delivery to the kidneys. In adults having heart surgery, this treatment lowered the chance of kidney injury, but it has not been tested in children. The amino acid solution used in this study, TrophAmine, is already used routinely in children's hospitals as part of IV nutrition.
The main questions this study aims to answer are:
Neither the families nor the medical team will know which solution a child receives. About 270 children younger than 18 years undergoing certain higher-risk heart surgeries will take part at three hospitals: Cincinnati Children's Hospital Medical Center, UPMC Children's Hospital of Pittsburgh, and Nationwide Children's Hospital.
Participants will:
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's planned enrollment of 270 is above the median of 100 across 786 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 134 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 31 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Amino acid infusion of 2 grams/kg/day; maximum of 100 grams/day
Drug: Amino Acid infusion
Volume matched to the Amino Acid Arm
Drug: Lactated Ringer Solution
Amino acid infusion of 2 grams/kilogram of participant weight/day for up to 72 hours.
Also known as: TrophAmine
Placebo infusion to match the volume of the amino acid infusion in gram/kilogram/day
Persistent Acute Kidney Injury
Acute kidney injury defined by KDIGO serum creatinine criteria lasting greater than 48 hours.
Time frame: Acute kidney injury lasting more than 48 hours after cardiopulmonary bypass exposure.
Urine NGAL, KIM-1 and L-FABP levels
Peak postoperative concentration, log-transformed and compared between arms using linear regression.
Time frame: preoperatively, 6-12 hours after cardiopulmonary bypass, postoperative days 1-2
Dichotomous AKI
KDIGO ≥1 using serum creatinine or urine output
Time frame: During the first 7 postoperative days
MAKE-90
Major Adverse Kidney Events
Time frame: 90 days after surgery
Ventilator Free Days
Days off the ventilator after surgery
Time frame: 28 days after surgery
Days alive and out of the hospital
Number of days alive and out of the hospital
Time frame: 90 days after surgery
No study locations are listed for this record.
Plan to share: No — With a relatively small data set, participants are at high risk of being re-identified using the data set details.
Start is estimated for Oct 2027; primary completion for Oct 2032, 60 months later.
Of 39 non-industry phase 2 interventional studies under Acute Kidney Injury, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 60 months is above that.
Counting every sponsor, half of 57 studies reached it within 29 months; a quarter within 16 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amino Acids
Children's Hospital Medical Center, Cincinnati →