Introduction of Hypo-osmolar ORS for Routine Use

Study Description

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Brief Summary:

The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

Condition or disease	Intervention/treatment	Phase
Diarrhoea	Drug: Hypo-osmolar ORS	Phase 4

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Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	75000 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Introduction of New Hypo-osmolar ORS Into Routine Use in the Management of Diarrhoeal Disease: a Phase IV Clinical Surveillance.
Study Start Date :	December 2002
Actual Primary Completion Date :	February 2004
Study Completion Date :	February 2004

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Incidence of symptomatic ( seizure/altered conciousness)hyponatremia(serum sodium < 130 m.mol/L)

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All age group Either sex Acute watery diarrhoea

Exclusion Criteria:

Diarrhoea with complication and other severe illness

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212

Sponsors and Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

United States Agency for International Development (USAID)

Investigators

Principal Investigator:	Nur H Alam, MD	International Centre for Diarrhoeal Disease Research, Bangladesh

More Information

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ClinicalTrials.gov Identifier:	NCT00244777 History of Changes
Other Study ID Numbers:	ICDDRB 2002-026
First Posted:	October 27, 2005
Last Update Posted:	June 12, 2015
Last Verified:	October 2005

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Seizure; Altered consciousness; Hyponatraemia; Diarrhoea; Hypo osmolar ORS

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms