Fluid Expansion As Supportive Therapy in critically ill African childre

Not Applicable

Completed

• Conditions: Severe illness with shock due to sepsis or severe malaria; Infections and Infestations; Other septicaemia

• Registration Number: ISRCTN69856593
• Lead Sponsor: Imperial College of Science, Technology and Medicine (UK)

Brief Summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21615299 2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23496872 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31196803 (added 17/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-21
• Study Completion: 2011-12-01
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3141

Inclusion Criteria

Children (both males and females, age range >60 days and <12 years) with severe illness and clinical evidence of impaired perfusion in whom there is uncertainty as to the benefits of immediate fluid resuscitation and what type of fluid to give.

Severe illness and impaired perfusion defined as follows:

1. Severe illness: one or more of the following:
1.1. Impaired consciousness: prostration or coma
1.2. Respiratory distress

Prostration: inability to sit unsupported, or to breast feed if < 9months
Coma: inability to localise a painful stimulus
Respiratory distress: Deep breathing or increased work of breathing

2. Impaired perfusion: one or more of the following:
2.1. Capillary refill time >2s
2.2. Lower limb temperature gradient
2.3. Weak radial pulse volume
2.4. Severe tachycardia

Severe tachycardia: if <12 months: >180 bpm; 12 months to 5 years: >160 bpm; >5 years: >140 bpm

Exclusion Criteria

One or more of the following at admission:
1. Severe acute malnutrition
2. Gastroenteritis
3. Conditions where intravascular volume expansion is contraindicated, namely chronic renal failure, pulmonary oedema
4. Non-infectious causes of severe illness: trauma, burns, intoxication
5. Children who have already received volume expansion using an isotonic volume expander during the current illness

Severe malnutrition: visible severe wasting and/or kwashiorkor
Gastroenteritis: >3 watery stools in previous 24 hours
Pulmonary oedema: oxygen saturation <90% on pulse oximetry plus bilateral basal crepitations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality at 48 hours after randomisation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mortality at 4 weeks after randomisation<br> 2. Mortality or neurological sequelae at 4 weeks after randomisation<br> 3. Neurological sequelae at 4 weeks after randomisation<br> 4. Persistent neurological sequelae at 6 months after randomisation<br> 5. Development of hypotensive shock within 48 hours of randomisation<br> 6. Adverse event within 48 hours of randomisation (pulmonary oedema, intracranial hypertension, severe allergic reaction in those receiving albumin)<br>