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Fluid expansion In severe Malnutrition

Phase II safety studies of volume expansion in children with severe malnutrition and features of hypovolaemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61146418
Enrollment
100
Registered
2007-10-31
Start date
2007-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition and hypovolaemia Nutritional, Metabolic, Endocrine Malnutrition and hypovolaemia

Interventions

Treatment will occur at the Site-Kilifi District Hospital, Kenya. Randomisation group A: children with diarrhoea - history of acute diarrhoea (greater than 6 watery stools/day) plus a feature of sho

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children greater than 6 months (either sex) with severe malnutrition defined as (one of the following): 1.1. Weight for height z score less than -3 or weight for height percentile (WAP) less than 70% 1.2. Mid-Upper Arm Circumference (MUAC) less than 11.0 cm 1.3. Oedema involving at least both feet (kwashiorkor) 2. Children who are admitted with, or develop during the course of admission, one or more of the following features of compensated or decompensated shock: 2.1. Depressed conscious state: prostration (inability to sit up) or coma (inability to localise a painful stimulus)* 2.2. Bradycardia (heart rate less than 80 beats per minute) 2.3. Evidence of shock or dehydration: 2.3.1. Capillary refill time greater than 2 seconds 2.3.2. Temperature gradient (from lower to upper part of leg elicited by running hand up the shin) 2.3.3. Weak pulse volume or systolic blood pressure less than 80 mmHg 2.3.4. Prolonged capillary refill greater than 2 seconds 2.4. Deep 'acidotic' breathing 2.5. Creatinine greater than 80 umols/L *only if still present after correction of hypoglycaemia

Exclusion criteria

Exclusion criteria: 1. Children of families who decline to consent 2. Haemoglobin less than or equal to 5 g/dl 3. Features of pulmonary oedema (defined as clinical evidence for presence of fine crepitations in both lungs plus oxygen saturations less than 90% in air) 4. Evidence of raised intracranial pressure (brain stem features of coning, systolic blood pressure greater than 90% centile for age plus falling heart rate and/or papilloedema) 5. Known congenital heart disease

Design outcomes

Primary

MeasureTime frame
Resolution of features of shock at 4 hours.

Secondary

MeasureTime frame
1. In-hospital death 2. Development of serious adverse events such as pulmonary oadema and raised intracranial pressure

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026