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New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects

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ClinicalTrials.gov Identifier: NCT00490932
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
Sponsor:
Information provided by:
Society for Applied Studies

Tracking Information
First Submitted Date  ICMJE June 22, 2007
First Posted Date  ICMJE June 25, 2007
Last Update Posted Date June 25, 2007
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects
Official Title  ICMJE 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 Description

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,

Duration: Total duration of the study will be 18 months.

Study subjects: The ID Hospital admitted approximately 23,000 patients with diarrhoea each year for the years 2001 and 2002. We expect that similar number of patients with diarrhoea will be admitted during the study period. We expect about 25 percent of them will be under five children. Based on many clinical trials with hypo-osmolar ORS formulations, we expect that symptomatic hypotraemia will be a rare event.

Inclusion Criteria: All patients admitted with diarrhoea over the study period of 12 months will be eligible for the study, which include men, women and children.

Surveillances for the adverse events: Medical Officers on duty at the Diarrhoea Ward of I.D. Hospital, under the supervision of a clinician scientist will look for the development of symptoms like seizure, lethargy or altered consciousness, or marked irritability (i.e., irritable to touch). The investigations for these patients will include the determination of blood glucose at bedside, serum electrolytes, and presence of fever. The decision to do a spinal tap will be left to the clinician in-charge of the patients in the hospital. CSF and blood culture will be done as and when indicated. Serum electrolyte measurements will be made available round the clock.

Data analysis: Adverse events with particular reference to seizures, marked lethargy and altered consciousness will be recorded. Their relation with hyponatraemia will be assessed and the rates of such events associated with hyponatraemia will be compared (and 95% confidence intervals will be calculated) with records from the preceding 12 months when the patients received only standard WHO ORS with 90 mmol/L sodium.

Primary outcome measures: Symptomatic hyponatraemia. It is defined as biochemical hyponatraemia associated with clinical features like convulsion or drowsiness or coma. A serum sodium of less than 130 mmol/L will be considered as hyponatraemia and a serum level less than 125 mmol/L will be considered as severe hyponatraemia.

Ethical Issues: The study will be conducted according to good clinical practice and the Declaration of Helsinki and Indian Council of Medical Research Guidelines.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diarrhea
  • Dysentery
Intervention  ICMJE Drug: Hypo-osmolar ORS
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2007)
27966
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients admitted with diarrhoea over the study period of 12 months will be eligible for the study, which include men, women and children.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00490932
Other Study ID Numbers  ICMJE ID04001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Society for Applied Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Dilip Mahalanabis, MBBS Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)
PRS Account Society for Applied Studies
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP