Preventing cell-free haemoglobin renal toxicity and ameliorating Acute Kidney Injury (AKI) in children with haemoglobinuric severe malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
A. Paracetamol intervention dose arm: research nurses will administer paracetamol 20 mg/kg orally 6-hourly for 48 h. Patients unable to swallow will receive paracetamol by nasogastric tube. If the pat
After screening, the patients that qualify will be assigned study numbers which correspond to those assigned in envelopes which are arranged consecutively in sealed opaque envelopes, each assigned acr
Sponsors
European & Developing Countries Clinical Trials Partnership
Eligibility
Sex/Gender
All
Age
6 Months to 12 Years
Inclusion criteria
Inclusion criteria: 1. Children aged >6 months to <12 years 2. Positive RDT for P. falciparum malaria at admission 3. One of the following features of severe malaria confirmed haemoglobinuria, impaired consciousness and/or severe respiratory distress 4. Guardian or parent willing and able to provide consent
Exclusion criteria
Exclusion criteria: 1. Surgery 2. Acute trauma or burns 3. Known allergy to paracetamol 4. Impaired liver function tests 5. Known chronic renal failure or suspected non-malarial causes of renal impairment 6. Refusal to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correction of AKI at 48 hours, as indicated by BUN (<20 mmol/L), creatinine level (<80 mmol/L), normal glomerular filtration index (based on Schwartz criteria), plasma creatinine, BUN, urinary-plasma creatinine ratio, serum urea-creatinine ratio, urinary osmolality, urinary-plasma osmolality ratio and urine microscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Survival measured using mortality outcome at 48 h and day 28 2. Resolution of AKI measured using BUN (<20 mmol/L), creatinine level (<80 mmol/L) at day 28, 90 and 180 | — |
Countries
Uganda
Outcome results
None listed