Clinical Trial: Validation of a Dehydration Scoring System

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Validation of a Dehydration Scoring System

Brief Summary: This is a study to evaluate the validity, reliability, and clinical usefulness of a new dehydration scoring system (DSS).

Detailed Summary:

RESEARCH DESIGN AND METHODS

Objectives:

Objective 1: Validity; Objective 2: Reliability; Objective 3: To obtain preliminary data in determining the effectiveness of the Dehydration Scoring System in predicting resource utilization and disposition.

Study Design:

This will be a prospective study of patients presenting to the Emergency Department (ED) with clinical signs of dehydration. All previously healthy children aged 1 month (mo) up to 16 years of (yo) age with vomiting, diarrhea, or poor oral (PO) intake from presumed gastroenteritis will be eligible for inclusion after obtaining informed consent and assent if applicable. Exclusion criteria will include a history of cardiac or renal disease, diabetes mellitus (DM), malnutrition or failure to thrive (FTT), and any malabsorptive disorder or short gut syndrome . Children will further be excluded if they are clinically unstable, requiring immediate life saving interventions or if no parent or legal guardian is available for consent.

Clinical measures:

Upon obtaining informed consent, a data sheet will be started to gather study weights, dehydration scores at specified intervals, patient demographics and key clinical findings, as well as resource utilization (none, oral rehydration therapy (ORT), intravenous (IV) therapy, observation status, admission to the hospital). Information regarding whether the patients have received the rotavirus vaccine and how many doses will also be collected.

As part of standard of care, patients will be weighed using either a single infant or pediatric scale located in triage at presentation to the
Sponsor: Phoenix Children's Hospital

Current Primary Outcome: Change in weight compared to dehydration score. [ Time Frame: 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Phoenix Children's Hospital

Dates:
Date Received: July 1, 2009
Date Started: June 2009
Date Completion:
Last Updated: September 2, 2011
Last Verified: September 2011