CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Insulindrug
Likely dose
Insulin 110 mgfrom 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/NCT00605696
NCT00605696Phase 2Completed
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Early Insulin Therapy and Development of Acute Respiratory Distress Syndrome

Albert Einstein College of Medicine·interventional·Posted Jan 31, 2008·Updated May 7, 2018

In Brief

A Phase 2 clinical trial evaluating Insulin for Respiratory Distress Syndrome, Adult and 2 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an original injury or illness, and people with ALI/ARDS typically require care in the intensive care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of this study is to examine if early infusions of insulin, known as intensive insulin therapy (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars and severe infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome, Adult, Sepsis, Hyperglycemia
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2008
Enrollment StartApr 1, 2008
Primary CompletionDec 1, 2011
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.4 years ago

Interventions

Insulindrug

Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.