Clinical Trial: New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management– Surveillance Study for Adverse Effects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Introduction of New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Management of Diarrhoeal Diseases – A Phase IV Surveillance Study
Brief Summary:
For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period.
Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
Detailed Summary:
It will be a Phase IV surveillance study of adverse effects, particularly symptomatic hyponatraemia associated with routine use of hypo-osmolar ORS solution in the treatment of diarrhoea patients of all ages and of any aetiology in a hospital that admits a large number of diarrhoea patients.
Objectives: To monitor symptomatic hyponatraemia over a completed year in a hospital treating a large number of patients with diarrhoea including cholera where all patients will be treated with low osmolarity ORS
Study Design: It will be a phase IV surveillance study of adverse effects, particularly symptomatic hyponatraemia associated with routine use of hypo-osmolar ORS solution in the treatment of diarrhoea patients of all ages and of any aetiology in a hospital that admits a large number of diarrhoea patients. Hypo-osmolar ORS as recommended by WHO is now being routinely used for all patients admitted to a hospital which admits a large number of diarrhoea patients including cholera. The hospital serves a metropolitan city and it’s suburbs known to be endemic for cholera.
Hypothesis: We hypothesise that routine use of the recommended hypo-osmolar ORS will not be associated with a significantly incidence rate of symptomatic hyponatraemia.
Study Site and Population: The study will be conducted in the Infectious Diseases Hospital, Beliaghata, Kolkata. This hospital admits diarrhoea patients of all ages including cholera. The hospital has 3 diarrhoea wards, one for adult men, one for adult women and one for children. It is the designated hospital for admitting all clinically suspected cholera patients from greater Calcutta. Of the total diarrhoea admissions during 1995 to 2002, a little over 25% were children under five,
Sponsor: Society for Applied Studies
Current Primary Outcome: Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.
Original Primary Outcome: Same as current
Current Secondary Outcome: Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale
Original Secondary Outcome: Same as current
Information By: Society for Applied Studies
Dates:
Date Received: June 22, 2007
Date Started: March 2005
Date Completion:
Last Updated: June 22, 2007
Last Verified: February 2007
