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NCT01401634 · ClinicalTrials.gov registry record · Phase 1

Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department

A Phase 1 study, sponsored by University of Southern California.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target

NCT01401634 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 80 participants.

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The verdict

NCT01401634, a Phase 1 study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target

Study 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.

Interventions

  • OTHER Intravenous normal saline
  • OTHER Oral water

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2011-01
Phase Phase 1

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT01401634

The ClinicalTrials.gov registry entry for NCT01401634 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Intravenous normal saline is the first listed.

NCT01401634 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01401634 about?

NCT01401634 is a clinical study titled "Oral Hydration for Mild to Moderate Hyperglycemia in the Emergency Department". 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 rehydr...

What is the current status of trial NCT01401634?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2011-01.

What interventions are being tested in trial NCT01401634?

The interventions under investigation include: Intravenous normal saline (OTHER), Oral water (OTHER).

Who is sponsoring clinical trial NCT01401634?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.