CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
hylenex-facilitated subcutaneous Lactated Ringer's infusiondrug
Likely dose
hylenex-facilitated subcutaneous Lactated Ringer's infusion 1000 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00807885
NCT00807885Phase 4Completed

INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique Study (INFUSE-AT): A Randomized, Open-Label, Parallel Group, Phase IV, Study Evaluating the Techniques of Administration of Subcutaneous Fluids Enabled by Human Recombinant Hyaluronidase (Hylenex) in Healthy Adult Volunteers

Baxter Healthcare Corporation·interventional·Posted Dec 12, 2008·Updated Oct 26, 2011

In Brief

A Phase 4 clinical trial evaluating hylenex-facilitated subcutaneous Lactated Ringer's infusion for Dehydration. Completed, enrolled 100 participants across 2 sites.

Detailed Summary

The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDehydration
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2008
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.6 years ago

Interventions

hylenex-facilitated subcutaneous Lactated Ringer's infusiondrug

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution