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Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral water
Intravenous normal saline
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring Hyperglycemia Hydration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Intravenous Fluids

Oral Fluids

Arm Description

Intravenous fluids for patients with hyperglycemia is part of the standard protocol in our department

Outcomes

Primary Outcome Measures

Change in Blood Sugar
Patients will have their blood sugar checked every 30 minutes for 2 hours

Secondary Outcome Measures

Full Information

First Posted
July 21, 2011
Last Updated
July 22, 2011
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT01401634
Brief Title
Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Southern California

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Hyperglycemia Hydration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous Fluids
Arm Type
Other
Arm Description
Intravenous fluids for patients with hyperglycemia is part of the standard protocol in our department
Arm Title
Oral Fluids
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Oral water
Intervention Description
2 Liters of water given orally
Intervention Type
Other
Intervention Name(s)
Intravenous normal saline
Intervention Description
2 Liters Intravenous normal saline
Primary Outcome Measure Information:
Title
Change in Blood Sugar
Description
Patients will have their blood sugar checked every 30 minutes for 2 hours
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

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