Introduction of Hypo-osmolar ORS for Routine Use

NCT00244777 | Completed Phase 4

• 1 other identifier: 2002-026
• Study Type: interventional
• Target: 75,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Interventions

Hypo-osmolar ORS DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All age group Either sex Acute watery diarrhoea

You may not qualify if:

• Diarrhoea with complication and other severe illness

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea; Seizures; Hyponatremia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nur H Alam, MD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 27, 2005
• Study Start: December 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: February 11, 2022

Record last verified: 2005-10

Locations

BA (1)