Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT01401634
Collaborator
(none)
80
1
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Oral water
  • Other: Intravenous normal saline
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

  1. Change in Blood Sugar [2 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01401634
Other Study ID Numbers:
  • HS-10-00223
First Posted:
Jul 25, 2011
Last Update Posted:
Jul 25, 2011
Last Verified:
Jul 1, 2011
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 25, 2011