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.
Phase:
Phase 4
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborator:
United States Agency for International Development (USAID)