Protein dose and recovery in critically ill patients with acute kidney injury
Official title: Effect of Protein Dosage on Persistent Acute Renal Failure in Critically Ill Patients.
Run by Hospital Italiano de Buenos Aires · NCT07631221 · Data updated 2026-11-12
In this study, researchers look at whether giving more than 1.2 g/kg/day of protein to ICU patients with AKI affects how quickly kidney recovery happens.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 344 (estimated) |
| Sponsor | Hospital Italiano de Buenos Aires Academic / other |
| Locations | 6 sites (Buenos Aires, Buenos Aires and 5 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | August 31, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07631221 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) in the ICU with AKI or acute worsening CKD receiving exclusive enteral/parenteral nutrition and meeting KDIGO criteria.
✕Probably not a fit
Patients with chronic kidney disease on dialysis at admission, those with severe liver disease, BMI > 30, or on renal replacement therapy at baseline may not benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses a target trial emulation approach to compare higher versus standard/lower protein intake on day five of ICU admission in adults with AKI or worsening CKD. Participants receive exclusive enteral or parenteral nutrition and are followed for kidney recovery outcomes and related health measures. The study leverages existing clinical data from three Buenos Aires hospitals to explore potential associations between protein dose and AKI duration. Although prior trials have suggested potential benefits or harms of high protein, this analysis focuses on the AKI population under real-world critical care conditions. No interventions are assigned by the researchers; exposure is defined by the protein dose recorded in medical records.
Why it matters
Potential benefit: If higher protein intake is shown to shorten AKI duration or improve kidney outcomes, treatment protocols could be adjusted to optimize nutrition in critically ill patients.
How similar studies have gone: Prior work like the EFFORT Protein study has suggested mixed results, with potential harm in certain severely ill AKI patients, making this targeted evaluation in AKI patients relevant and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older admitted to the ICU. * Patients receiving exclusive enteral or parenteral nutrition * Acute kidney injury or exacerbated chronic kidney disease according to KDIGO criteria (increase in creatinine greater than 0.3 mg/dL in less than 48 hours or a 1.5-fold increase in baseline creatinine in 7 days) Exclusion Criteria: * Patients diagnosed with chronic kidney disease with a creatinine clearance of less than 30 ml/min/m2 or on dialysis at admission. * Patients with a history of kidney transplantation * Patients with severe liver disease (Child-Pugh score \>7 points) * Patients with acute kidney injury undergoing renal replacement therapy at T0 * BMI\> 30
Where it's running
-
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina Recruiting -
Hospital Privado Universitario de Córdoba
Córdoba, Córdoba Province, Argentina Recruiting -
Hospital Universitario Austral
Buenos Aires, Pilar, Argentina Recruiting -
Hospital Italiano sede San Justo Agustín Rocca
Buenos Aires, San Justo, Argentina Recruiting -
Clinica Bazterrica
Buenos Aires, Buenos Aires, Argentina Not yet recruiting -
Hospital Alemán
Buenos Aires, Buenos Aires F.D., Argentina Not yet recruiting
Study contacts
- Study coordinator: Ivan Alfredo Huespe, MS
- Email: ivan.huespe@hospitalitaliano.org.ar
- Phone: +54949590200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.