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A Study on the Role of N-Acetylcysteine as a Treatment for Acute Kidney Injury in Intensive Care Patients

Effect of N-Acetylcysteine in Patients with Acute Kidney Injury Admitted to the Medicine Intensive Care Unit: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105256
Enrollment
60
Registered
2026-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: N179- Acute kidney failure, unspecified

Interventions

Intervention1: Intravenous N-acetylcysteine: Intravenous N-acetylcysteine will be administered at a dose of 600 mg every 12 hours, with dose adjustments permitted based on study protocol or patient to
clinicians and patients remain blinded Standard of Care: Both arms receive standard of care for AKI and critical illness per ICU protocols: 1.Fluid management 2.Avoidance of nephrotoxins 3.Vasopress

Sponsors

Datta Meghe Institute Of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age greater than or equal to eighteen years. Adult patients of either sex will be eligible. 2. Diagnosed with Acute Kidney Injury as per Kidney Disease Improving Global Outcomes criteria, defined by any one of the following: Increase in serum creatinine by zero point three milligrams per deciliter or more within forty eight hours. Or increase in serum creatinine to one point five times or more than the baseline value within the previous seven days. Or urine output less than zero point five milliliters per kilogram per hour for at least six hours. 3. Admitted to the Medical Intensive Care Unit 4. Acute Kidney Injury diagnosed within twenty four hours of Intensive Care Unit admission. 5. Willingness to participate in the study. Written informed consent must be obtained from the patient. If the patient is unable to provide consent, written informed consent must be obtained from a legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Patients with known Chronic Kidney Disease presenting acutely with Acute Kidney Injury. 2. Patients with pre renal Acute Kidney Injury due to conditions such as hypovolemia, congestive cardiac failure, liver failure, or hepatorenal syndrome. 3. Patients in shock, including hypovolemic shock or cardiogenic shock, at the time of enrollment. 4. Known Chronic Kidney Disease Stage four or Stage five, defined as estimated glomerular filtration rate less than thirty milliliters per minute per one point seven three square meters. 5. Patients already receiving renal replacement therapy at the time of enrollment. 6. Known hypersensitivity or allergy to N Acetylcysteine. 7. Pregnant or lactating women. 8. Patients with multiorgan failure, defined as Sequential Organ Failure Assessment score greater than fifteen at the time of enrollment. 9. Participation in another interventional clinical study at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
1.Improvement in renal function, assessed by: Change in serum creatinine levels over 48 72 hours Change in estimated glomerular filtration rate (eGFR) Urine output over 24 72 hours Timepoint: 72 hours

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDr Shilpa Bawankule

Datta Meghe Institute Of Higher Education

drshilpagadhane@gmail.com9673288822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026