Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

This study has been completed.
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01401634
First received: July 21, 2011
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

Diabetes and high blood sugar are extremely common among patients presenting to US Emergency Departments. Intravenous fluids with or without insulin are often used to treat these patients. However, simple, low-cost interventions, such oral hydration have not been studied in this context. Oral rehydration may be better than no therapy at all, which is often what these patients receive in the first few hours when presenting to busy, overcrowded Emergency Department (ED) with long wait times, or in resource-poor environments such as developing countries. The investigators propose a study to see if oral hydration for adult patients presenting to the ED with high blood sugar i.e. finger-stick (FS) values between 250 and 500 mg/dL can help lower blood sugar at the same rate as intravenous fluids. Half the patients will be given intravenous fluids per our department protocol, while the other half of the patients will be given 2 liters of water to drink over a 1-hour period. Both groups will have their blood sugar measured every 30 mins for 2 hours. The investigators will analyze the data to determine if there is a statistically significant difference in blood sugar between the two groups within 2 hours.


Condition Intervention Phase
Hyperglycemia
Other: Oral water
Other: Intravenous normal saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Change in Blood Sugar [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Patients will have their blood sugar checked every 30 minutes for 2 hours


Estimated Enrollment: 80
Study Start Date: January 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravenous Fluids
Intravenous fluids for patients with hyperglycemia is part of the standard protocol in our department
Other: Intravenous normal saline
2 Liters Intravenous normal saline
Experimental: Oral Fluids Other: Oral water
2 Liters of water given orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient, above the age of 18 years old, presenting to Emergency Department triage with a fingerstick glucose between 250 and 500 mg/dL

Exclusion Criteria:

  • Patients with evidence of DKA (hyperglycemia with ketonuria and abnormal pH or bicarbonate on venous blood gas), HHS, or other critical illnesses requiring immediate medical attention (as determined by ED triage nurses),
  • end-stage renal disease requiring dialysis through an arterio-venous shunt or fistula,
  • abnormal mental status (GCS < 15),
  • unstable vital signs including pulse > 100, SBP < 100, respiratory rate>20, (or any combination of vital signs not meeting these cutoffs but deemed worrisome by the triage nurse) or unable to tolerate oral intake/actively vomiting.
  • Patients who receive IV fluids prior to or during the study period.
  • Patients unable to communicate in English or Spanish.
  • Jail patients will also be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401634

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
  More Information

No publications provided

Responsible Party: Sanjay Arora MD, University of Southern California
ClinicalTrials.gov Identifier: NCT01401634     History of Changes
Other Study ID Numbers: HS-10-00223
Study First Received: July 21, 2011
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Hyperglycemia Hydration

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014