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

NCT02203019 | Completed Phase 4 Results DMC

• 1 other identifier: L14-136
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Respiratory Failure; Agitation

Keywords

Dexmedetomidine; Propofol; Sepsis; Mechanical Ventilation; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Duration of Mechanical Ventilation

  Number of days patient requires mechanical ventilation

  Up to 28 days

Secondary Outcomes (3)

• Duration of MICU Stay

  Up to 28 Days

• Duration of Vasopressor Support

  Up to 28 Days

• Mortality

  Up to 28 Days

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Propofol will be administered for sedation.

Drug: Propofol; Drug: Fentanyl

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine will be administered for sedation

Drug: Dexmedetomidine; Drug: Fentanyl

Interventions

Propofol DRUG

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

Also known as: Diprivan

Propofol

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Fentanyl DRUG

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

Dexmedetomidine; Propofol

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-89 years old
• with the diagnosis of sepsis (as specified below) within the previous 24 hours
• who require mechanical ventilation, and
• provide informed consent either personally or by an authorized representative.

You may not qualify if:

• Patients with documented allergies to propofol, dexmedetomidine, fentanyl, eggs or egg products, or soy or soy products.
• A heart rate less than 50 beats/minute or grade 2 or 3 AV heart block
• Mean arterial pressure less than 55 mmHg despite appropriate fluid resuscitation and vasopressor support.
• Current triglyceride level \> 400 mg/dl

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

University Medical Center

Lubbock, Texas, 79415, United States

Location

Related Publications (6)

• 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.

  PMID: 16540958 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.

  PMID: 18073360 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.

  PMID: 20233428 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.

  PMID: 22436955 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.

  PMID: 1597042 BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Sepsis; Respiratory Insufficiency; Psychomotor Agitation

Interventions

Propofol; Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Results Point of Contact

• Title: Dr Kenneth Nugent
• Organization: Texas Tech University

kenneth.nugent@ttuhsc.edu

18067436847

Study Officials

• Kenneth Nugent, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: August 1, 2014
• Primary Completion: September 22, 2016
• Study Completion: September 22, 2016
• Last Updated: March 2, 2020
• Results First Posted: March 2, 2020

Record last verified: 2020-02

Locations

US (1)