Prevention of Renal Outcomes from contrast-induced Nephropathy with amino acids vs saline Therapy in critically ill patients: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260118006

Enrollment

184

Registered

2026-01-18

Start date

2026-01-11

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute kidney injury (AKI) is a rapid decline in renal function defined by the KDIGO 2012 criteria as an increase in serum creatinine or reduced urine output, and one important cause is contrast-induced nephropathy (CIN), which occurs within 48 hours after exposure to iodinated contrast media and is more common in high-risk patients such as those with chronic kidney disease, diabetes, heart failure, advanced age, or concurrent nephrotoxic drug use, leading to increased morbidity, mortality, and p

Interventions

Patients in the amino acid group received an intravenous amino acid solution (1000 milliliters containing 70 grams of amino acids), administered at a dose of 1 gram per ideal body weight, with a maxim

Experimental Drug,Placebo Comparator Drug

Amino acid,Normal saline

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Adult patients aged 18 years or older admitted to the intensive care unit (ICU). 2.Patients with an estimated glomerular filtration rate of 60 milliliters per minute per 1.73 square meters or less, or acute kidney injury stage 1 or stage 2 according to KDIGO criteria. 3.Patients with a clinical indication for the administration of iodinated contrast media for diagnostic or therapeutic purposes.

Exclusion criteria

Exclusion criteria: 1.Patients with end stage chronic kidney disease or those receiving renal replacement therapy. 2.Pregnant patients. 3.Breastfeeding patients. 4.Patients with a history of amino acid allergy. 5.Patients with disorders of amino acid metabolism. 6.Patients with a history of allergic reaction to iodinated contrast media. 7.Patients with pulmonary edema. 8.Terminally ill patients or patients who decline further medical treatment.

Design outcomes

Primary

Measure	Time frame
contrast induced nephropathy 48 hour Serum creatinine	—

Secondary

Measure	Time frame
50 percent or greater increase in serum creatinine Day 7 Serum creatinine,AKI severity 48 hours Serum creatinine,complications 24 hours observing clinical	—

Countries

Thailand

Contacts

Public ContactThummaporn Naorungroj

Siriraj hospital

thummaporn.nao@mahidol.ac.th024198597

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026