‘Effectiveness and safety of the use of N-acetylcysteine in patients with kidney failure in leptospirosis’
- Conditions
- eptospirosis, Acute kidney injury
- Registration Number
- SLCTR/2018/016
- Lead Sponsor
- ational Research Council of Sri Lanka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Male and female subjects aged 18 years and above
2. Confirmed diagnosis of leptospirosis as determined by Leptospirosis Immunochromatography test and Leptospirosis Microscopic Agglutination Test
3. Acute kidney injury, defined based on Kidney Disease Improving Global Outcomes criteria: (KDIGO criteria).
1. Patients with clinical or serological evidence of co-infection with dengue or Hanta virus
2. Patients on nitrates and other antioxidant medication including vitamin E supplementation
3. Superadded pulmonary hemorrhages as a complication of leptospirosis
4. Patients with acute liver dysfunction defined as: clinical evidence of encephalopathy and or evidence of coagulopathy with INR>1.5 with significant jaundice and a total serum bilirubin level of >100 µmol/L
5. Patients in cardiogenic or septic shock as a complication of leptospirosis
6. Pregnancy – All female patients will undergo urinary beta HcG testing prior to inclusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Renal replacement therapy free survival at 30 days <br><br>2. Mortality at 30 days [30 days]<br>
- Secondary Outcome Measures
Name Time Method