Status:
COMPLETED
Drug Nephrotoxicity Amelioration by N-acetylcysteine
Lead Sponsor:
Helwan University
Conditions:
Drug-Induced Nephropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
When treating individuals with febrile neutropenia, amphotericin B (AmB-d) is one of the most effective treatments against often fatal systemic fungal infections.Nephrotoxicity from amphotericin B can...
Detailed Description
Severe fungal infections continue to be a significant source of morbidity and mortality in haematology units despite recent therapeutic advancements. The first anti-fungal medication that was successf...
Eligibility Criteria
Inclusion
- Age more than 18 years.
- Patients who have indication for systemic (injection) for conventional amphotericin at least 7 days.
Exclusion
- documented acute kidney injury defined by an increase in serum creatinine ‡ 0.3 mg/dl within 48 h, or an increase in serum creatinine by ‡ 1.5 times baseline within the prior 7 days, or urine volume \<0.5 ml/kg/h for 6 h
- documented chronic kidney disease (clearance creatinine below 60 ml/min/1.73 m2 calculated by the abbreviated Modification of Diet in Renal Disease equation), history of peritoneal or hemodialysis for \> 3 months
- sepsis
- Severe hemorrhage(Blood loss \> 3 litres)
- Patient with cardiac or chronic liver disease history of receiving AmB by any administration route within the recent 14 days known allergy to either amphotericin b or N-acetylcysteine.
- receiving any formulation of NAC within the last week.
- unable to tolerate oral intake.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06122311
Start Date
August 25 2023
End Date
June 10 2024
Last Update
July 5 2024
Active Locations (1)
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1
Helwan University
Cairo, Egypt