CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Propofol +2 moredrug
Likely dose
Not stated in 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/NCT02203019
NCT02203019Phase 4Completed

PRO-DEFENSE: Propofol Versus Dexmedetomidine for Sedation in Mechanically Ventilated Patients With Sepsis

Texas Tech University Health Sciences Center·interventional·Posted Jul 29, 2014·Updated Mar 2, 2020

In Brief

A Phase 4 clinical trial evaluating Propofol, Dexmedetomidine, and 1 other intervention for Sepsis and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Patients with infections in their blood often become very sick. These patients are usually put in an intensive care unit for careful observation and treatment. These patients may develop a low blood pressure, lung failure, and kidney failure. When these problems develop, care becomes quite complicated. Patients with lung failure often need help with a breathing machine to make certain that the breathing is adequate. The machine helps keep the oxygen level high enough for healthy tissues. When patients are placed on the machine for breathing they require a tube to be placed into lungs. This can be quite uncomfortable. These patients need sedation to help them tolerate the uncomfortable breathing tube and other parts of their routine necessary care. This study will compare two drugs (dexmedetomidine and propofol) which are frequently used for sedation in intensive care patients. Clinical studies suggest that these drugs are both effective and safe. The main question is whether or not one of the drugs is better in a patient with a blood infection. This study will try to determine that. Our main goal is to see whether or not patients on one particular drug come off the breathing machine faster than patients on the other drug. These drugs are not experimental drugs and are approved by the Food and Drug Administration. There is no placebo drug being used in this study. All patients in this study will receive the best possible care based on their medical condition.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 29, 2014
Enrollment StartAug 1, 2014
Primary CompletionSep 22, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.9 years ago

Interventions

Propofoldrug

Propofol will be administered for sedation in mechanically ventilated patients with sepsis.

Dexmedetomidinedrug

Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis.

Fentanyldrug

Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".