Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure

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.

Timeline

Start

2014-08

Primary completion

2016-09-22

Completion

2016-09-22

Publications

• Background Carson SS, Kress JP, Rodgers JE, Vinayak A, Campbell-Bright S, Levitt J, Bourdet S, Ivanova A, Henderson AG, Pohlman A, Chang L, Rich PB, Hall J. A randomized trial of intermittent lorazepam versus propofol with daily interruption in mechanically ventilated patients. Crit Care Med. 2006 May;34(5):1326-32. doi: 10.1097/01.CCM.0000215513.63207.7F.
• Background Pandharipande PP, Pun BT, Herr DL, Maze M, Girard TD, Miller RR, Shintani AK, Thompson JL, Jackson JC, Deppen SA, Stiles RA, Dittus RS, Bernard GR, Ely EW. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007 Dec 12;298(22):2644-53. doi: 10.1001/jama.298.22.2644.
• Background Pandharipande PP, Sanders RD, Girard TD, McGrane S, Thompson JL, Shintani AK, Herr DL, Maze M, Ely EW; MENDS investigators. Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial. Crit Care. 2010;14(2):R38. doi: 10.1186/cc8916. Epub 2010 Mar 16.
• Background Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
• Background American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med. 1992 Jun;20(6):864-74.
• Results Sigler MB, Islam EA, Nugent K. Comparison of dexmedetomidine and propofol in mechanically ventilated patients with sepsis: a pilot study. The Southwest Respiratory and Critical Care Chronicles 2018;6(22):10-15.

Drugs

Indications