Severe acute malnutrition Nutritional, Metabolic, Endocrine Severe acute malnutrition and dehydration due to gastroenteritis
Conditions
Interventions
Randomisation lists are generated and kept at the MRC CTU at UCL, London. The randomisation envelopes are prepared before the trial at the Clinical trials facility, KWTRP, Kilifi. These contain the ac
Sponsors
Imperial College, London
Eligibility
Sex/Gender
All
Age
60 Days to 12 Years
Inclusion criteria
Inclusion criteria: Severe dehydration - Stratum A: 1. Aged 60 days to 12 years 2. Severe malnutrition defined as any of the following: Mid-upper arm circumference (MUAC) 3 loose stools per day 4. Signs of severe dehydration, defined (as per WHO definition) as at least one of the following: unable to drink, Alert Voice Pain Unresponsive scale (AVPU) 2 seconds) or inability to take or retain oral fluids, and/or shock (defined as patient with cold peripheries, weak and fast pulse and capillary refill time > 3 seconds) Moderate/some dehydration - Stratum B: 1. Aged 60 days to 12 years 2. Severe acute malnutrition criteria, complicated by dehydrating diarrhoea (defined as > 3 loose stools per day) 3. Some to moderate dehydration or completing management of severe dehydration. Some to moderate dehydration defined as two of the following: restlessness, irritability, thirst, sunken eyes or skin pinch goes back slowly
Exclusion criteria
Exclusion criteria: 1. Diarrhoea lasting more than 14 days 2. Known congenital or rheumatic heart disease 3. Refusal of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 07/08/2023: 1. For the intravenous rehydration strategy, mortality at 96 h after enrolment 2. For the oral rehydration strategy, change in plasma sodium levels, measured by standard laboratory clinical chemistry analyser from baseline (time of enrolment) to 24 h after enrolment _____ Previous primary outcome measures: 1. For intravenous rehydration, urine output (ml/kg/hour) will be assessed as a surrogate marker of rehydration efficacy 8 hours after treatment 2. Change in plasma sodium levels, measured by standard laboratory clinical chemistry analyser at the baseline (time of enrolment) and after 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evidence of pulmonary oedema or heart failure during period of hospital admission: 1.1. Pulmonary oedema defined as developed of bilateral bi-basal crepitations of lungs on clinical examination 1.2. Heart failure defined as development of signs of severe tachycardia, elevated jugular venous pressure and de novo or increasing hepatomegaly 2. Changes in sodium from post-IV levels for those in Stratum A, measured using standard laboratory clinical chemistry analyser at the baseline and after intravenous rehydration is completed 3. Perturbations of electrolyte abnormalities (severe hyponatraemia < 125 mmol/l or hypokalaemia < 2.5 mol/l), measured by standard laboratory clinical chemistry analyser at the baseline and at any time during admission 4. Mid-upper arm circumference (MUAC) change, measured using MUAC tape (supplied by UNICEF) at the baseline and day 7 5. Survival at day 28 (child is confirmed to be alive at day 28) | — |
Countries
Kenya, Niger, Nigeria, Uganda
Contacts
Public ContactEmmanuel Oguda
Outcome results
None listed