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Clinical Trials/NCT01401634
NCT01401634
Completed
Phase 1

Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

University of Southern California1 site in 1 country80 target enrollmentJanuary 2011
ConditionsHyperglycemia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hyperglycemia
Sponsor
University of Southern California
Enrollment
80
Locations
1
Primary Endpoint
Change in Blood Sugar
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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.

Outcomes

Primary Outcomes

Change in Blood Sugar

Time Frame: 2 hours

Patients will have their blood sugar checked every 30 minutes for 2 hours

Study Sites (1)

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