Chronic kidney disease progression following severe malaria-associated acute kidney injury Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Severe malaria: 1. Aged between 90 days and <16 years of age 2. Require inpatient hospitalization 3. Have a clinical diagnosis of severe malaria supported by a positive rapid diagnostic test for Plasmodium falciparum HRP-2 antigen, or direct visualization of asexual parasites by microscopy. Community children: 1. Aged between 90 days and <16 years of age 2. Live in the same or neighboring household as a child with severe malaria
Exclusion criteria
Exclusion criteria: Severe malaria: 1. Children on maintenance dialysis or known to have chronic kidney disease 2. The presence of congenital heart disease, pre-existing neurological disease or cerebral palsy 3. Enrollment in another study that may affect participation Community children: 1. The same as those for children with severe malaria, but also include a previous hospitalization 1. A history of illness requiring medical treatment or medication use in the previous four weeks 3. Evidence of fever or active illness on physical examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chronic kidney disease (CKD), defined as an eGFR <90 ml/min/1.73 m2 using the U25 eGFR formula or age-specific albuminuria sustained over 3 months, measured at at 1, 2, 4, 12, 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hypertension (stage 2) (systolic or diastolic blood pressure of 99% or >140/90 mmHg) at scheduled follow-up visits at 1, 2, 4, 12 and 24 months 2. Acute kidney disease (AKD), defined as AKI present for more than 7 days or the presence of low eGFR at scheduled follow-up visits at 1, 2, 4, 12 and 24 months 3. Cognitive deficits measured using the Kaufman Assessment Battery for Children, Second Edition (KABC-II) at 12 and 24 months follow-up 4. Behavioral problems measured using the Child Behavior Checklist (CBCL) at 12 and 24 months follow-up 5. Cerebral edema, defined using apparent diffusion coefficient maps of Magnetic Resonance Images during hospitalization 6. Health-related quality of life measured using the Pediatric Quality of Life Inventory (PedsQL) over scheduled follow-up visits at 1, 2, 4, 12 and 24 months 7. Post-discharge mortality based on parental report over the 24-month follow-up period. 8. Hyperfiltration, defined as sustained eGFR >180 ml/min per 1.73m2, using serum creatinine over follow-up | — |
Countries
Uganda