Introduction of Hypo-Osmolar ORS for Routine Use

This study has been completed.
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00244777
First received: October 26, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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 Intervention Phase
Diarrhoea
Drug: Hypo-osmolar ORS
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

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

Estimated Enrollment: 75000
Study Start Date: December 2002
Estimated Study Completion Date: February 2004
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244777

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

No publications provided

ClinicalTrials.gov Identifier: NCT00244777     History of Changes
Other Study ID Numbers: ICDDRB 2002-026
Study First Received: October 26, 2005
Last Updated: October 26, 2005
Health Authority: Bangladesh: Ethical Review Committee

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

ClinicalTrials.gov processed this record on August 28, 2014