Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103852542919 Date of Approval: 23/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rehydration of children with severe malnutrition and gastroenteritis
Official scientific title GASTROENTERITIS REHYDRATION OF CHILDREN WITH SEVERE ACUTE MALNUTRITION (GASTRO-SAM).
Brief summary describing the background and objectives of the trial In African children with severe acute malnutrition (SAM) who have been admitted to hospital with gastroenteritis (≥3 watery stools/day). The outcome in such children when they are managed in accordance to World Health Organization (WHO) SAM treatment guideline is very poor with over 20% dying during hospital admission. Rehydration guidelines for SAM are exceptionally conservative and controversial, relying upon expert opinion, that restrict intravenous fluids to cases with advanced shock and exclusive use of low sodium intravenous and oral rehydration solutions (ORS) for fear of fluid and/or sodium overload. We propose that standard rehydration strategies that are given to other children with SAM for both iv and oral rehydration in SAM children with diarrhoea may reduce adverse outcomes. The trial will enrol African children in 4 countries Kenya, Uganda, Niger and Nigeria (across 7 centres). In a trial with two strata: in Stratum A (severe dehydration) 272 children will be randomised (1:1:2) to WHO Plan C arm (100mls/kg Ringers Lactate (RL) over 3-6 hours (n=68) according to age including boluses for shock versus slow rehydration (100 mls/kg RL over 8 hours and no boluses (n=68) or WHO SAM rehydration regime: ORS only (boluses for shock (standard of care) (n=136). Stratum B (n=200) incorporates children presenting with some dehydration (n=64) or severe dehydration post-rehydration (n=272) compares (1:1 ratio) standard WHO ORS given for non-SAM (experimental n=100) versus WHO SAM-recommended low-sodium RESOMAL (control n=100). Primary outcome for intravenous rehydration mortality to 96 hours and for oral rehydration a change from randomisation in sodium levels at 24 hours. This trial will also generate safety data on survival to 28 days.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GASTROSAM
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Diarrhoea Severe Acute Malnutrition
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2018
Actual trial start date 27/08/2019
Anticipated date of last follow up 31/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 336
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ISRCTN76149273 ISRCTN
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group WHO Plan C arm Ringers Lactate 100mls/kg 3-6 hours Rapid intravenous rehydration 34
Experimental Group Ringers Lactate 100mls/kg 8 hours Slow rehydration 34
Control Group No rehydration 0 0 WHO SAM rehydration guideline 68 Active-Treatment of Control Group
Experimental Group Low osmolarity Oral Rehydration Salts As much as they can drink 4 hours WHO Standard ORS (Plan B) rehydration 100
Control Group Low Sodium Oral Redration Salts for Malnutrtion As much as the child can drink 4 hours WHO severe malnutrition oral rehydration 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with SAM criteria (defined as any of: mid-upper arm circumference (MUAC) <11.5cm, WHZ <-3SD or kwashiorkor) Diarrhoea (>3 loose stool/day) Signs of severe dehydration Diarrhoea lasting more than 14-days Known congenital or rheumatic heart disease Refusal of consent Child: 6 Year-12 Year 6 Month(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/04/2018 Imperial College Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Medical School Building St Marys Campus London W2 1PG London W2 1PG United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/06/2019 Mbale Regional Hospital Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pallisa Road Mbale PO Box921 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/08/2020 KEMRI Scientific and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mbagathi Road Nairobi POB584840 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/07/2023 Medicine Sans Frontieres Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Arbre Benit Street Brussels 1050 Belgium
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stratum A intravenous rehydration mortality 96 hours
Primary Outcome Stratum B Oral rehydration Change from randomisationbaseline plasma sodium level 24 hours
Secondary Outcome Safety outcomes (evidence of pulmonary oedema or heart failure) During hospital admission
Secondary Outcome Development of electrolyte abnormalities (severe hyponatraemia <125 mmols/L or hypokalaemia <2.5 mol/L) During hospital admission
Secondary Outcome Weight gain from randomisation/baseline Day 7 post randomisation
Secondary Outcome Mortality Day 28 post randomisation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbale Regional Regional Referral Hospital Pallisa Road Mbale PO Box291 Uganda
Soroti Regional Referral Hospital Hospital Road Soroti PO Box289 Uganda
Kilifi County Hospital Hospital Road Kilifi PO Box230 Kenya
Coast General Teaching Hospital. Madakara Road Mombasa Kenya
Nilefa Kiji MSF Hospital Damboa Road Maiduguri Nigeria
Magaria Childrens Hospital Dan Chifini ville Magaria Niger
District Hospital de Madarounfa Maradi Road Maradi Niger
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council UK 1 Kemble Street London WC2B 4AN United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Imperial College London Medical School Building, St Marys Campus London W2 1PG United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Peter OlupotOlupot Pallisa Road Mbale PO Box291 Uganda
Mainga Hamaluba Hospital Road Kilifi PO Box230 Kenya
Elizabeth George MRC Clinical Trials Unit at UCL 90 High Holborn London WC1V 6LJ United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kathryn Maitland k.maitland@imperial.ac.uk +254721508749 KEMRI Wellcome Trust Unit
City Postal code Country Position/Affiliation
Kilifi PO Box230 Kenya Professor of Tropical Infectious Disease
Role Name Email Phone Street address
Public Enquiries Emmanuel Oguda EOguda@kemri-wellcome.org +254722719020 KWTRP, Hospital Road
City Postal code Country Position/Affiliation
Kilifi PO Box230 Kenya Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Kathryn Maitland k.maitland@imperial.ac.uk +254721508749 KWTRP Hospital Road
City Postal code Country Position/Affiliation
Kilifi PO Box230 Kenya Professor of Paediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months Requests for access to appropriately anonymized data from this trial can be made by application to the trial statistician at MRC-UCL (elizabeth.george@ucl.ac.uk)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information