Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401634
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : July 25, 2011
Information provided by:
University of Southern California

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperglycemia Other: Oral water Other: Intravenous normal saline Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in Blood Sugar [ Time Frame: 2 hours ]
    Patients will have their blood sugar checked every 30 minutes for 2 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01401634

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

Responsible Party: Sanjay Arora MD, University of Southern California Identifier: NCT01401634     History of Changes
Other Study ID Numbers: HS-10-00223
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by University of Southern California:
Hyperglycemia Hydration

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases