Leptospirosis, Acute kidney injury
Conditions
Interventions
The study will be carried out at the University Medical Unit, National Hospital of Sri Lanka, Colombo, Sri Lanka.
Simple randomization will be used to allocate participants into two groups (1:1 allo
Sponsors
National Research Council of Sri Lanka
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Renal replacement therapy free survival at 30 days 2. Mortality at 30 days [30 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of platelet count >100,000 2. Length of hospital stay 3. Improvement in parameters of oxidative stress and increase in antioxidant capacity – nitric oxide (NO) activity (with the surrogate combination assay of nitrates and nitrites (NOx), measurement of protein-carbonyl, antioxidant capacity (AOC) and lipid peroxidase. The level of improvement is noted at 25% from baseline measured values 4. Safety outcomes: Development of anaphylaxis with NAC and the following manifestations: angioedema, bronchospasm respiratory distress, hypotension. [1. Platelet count: at 12, 24, 48, and 60 hours and 30 days from initiating treatment. 2. Duration of hospital stay: on day 5 from initiating treatment, and at discharge 3. Antioxidant capacity: Serum samples collected at baseline, and at 12, 24, 48 and 60 hours from initiating treatment will be assessed for antioxidant capacity using Trolox equivalent antioxidant capacity. 4. Oxidative stress: Serum samples at baseline, and at 12, 24, 48 and 60 hours from initiating treatment will be assessed for nitric oxide, protein carbonyl and lipid hydroperoxidase levels. ] | — |
Countries
Sri Lanka
Contacts
Public ContactSenaka Rajapakse
Professor in Clinical Medicine and Consultant Physician
Outcome results
None listed