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Enteral Versus Intravenous Sedation in Critically Ill High-risk ICU Patients

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ClinicalTrials.gov Identifier: NCT01360346
Recruitment Status : Unknown
Verified April 2012 by Giovanni Mistraletti, University of Milan.
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : April 24, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
Recent studies suggest the employment of 'conscious' sedation (1) for critically high - risk patients (2), showing more efficacy then deep sedation (3). The investigators want to compare intravenous injection versus enteral sedative drugs administration, purposing to maintain a 'conscious' sedation level compatibly with the needed cares, invasive procedures, and medical and nursing surveillance.

Condition or disease Intervention/treatment Phase
Critical Illness Mechanical Ventilation Complication Procedure: Enteral Sedation (EN) Procedure: Control group: Intravenous Sedation (IV) Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicentric, Single Blind, Randomized Controlled Trial on Enteral Sedation Versus Intravenous Sedation in Critically Ill High-risk ICU Patients
Study Start Date : January 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Enteral Sedation (EN)
Melatonin, Hydroxyzine, and Lorazepam. At every work shift, it will be checked the possibility to decrease the Lorazepam and then the Hydroxyzine dosage to quickly obtain and continuously maintain a RASS level = 0
Procedure: Enteral Sedation (EN)
Intravenous propofol or midazolam administration at the ICU admission and stopped within 48h. Melatonin by enteral route (3mg x 2/die) from admission to discharge. Hydroxyzine by enteral route from ICU admission (600mg/die), decreased and stopped as soon as possible. Lorazepam supplementation (maximum 16mg/die) if hydroxyzine is inadequate.
Other Name: ENTERAL
Active Comparator: Intravenous Sedation (IV)
Intravenous propofol or midazolam administration at the ICU admission to discharge at the compatible lowest level with harsh ICU environment. At every shift nurses are requested to give intravenous lowest dosage to obtain RASS=0
Procedure: Control group: Intravenous Sedation (IV)
Propofol or midazolam from ICU admission to discharge at the compatible lowest level with harsh ICU environment.

Outcome Measures

Primary Outcome Measures :
  1. Percent of efficacy, measured by observed RASS = desired RASS ± 1. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Sedation protocol effectiveness: percentage of "protocol violation days" on the total of ICU days. [ Time Frame: One year ]
  2. Delirium and coma free days (respectively negative CAM-ICU and RASS > - 3 in all daily observations until 28° ICU day) (11) [ Time Frame: One year ]
  3. Ventilation free days (12) [ Time Frame: One year ]
  4. Nursing evaluation of sedation adequacy (communication skills, cooperation, environment tolerance) (13) [ Time Frame: One year ]
  5. Overall ICU and hospital mortality, absolute mortality after 1 year from ICU discharge. [ Time Frame: 24 months ]
  6. Sedative drugs costs. [ Time Frame: One year ]
  7. Indirect inefficacy markers [ Time Frame: One year ]
    1. Prevalence of 'dangerous episodes': self - extubation, removal of other invasive clinical instruments;
    2. Length of ICU and hospital stay
    3. Use of anti-psychotic drugs (indirect delirium marker)
    4. Other indicators of sedation failure: use of restraining therapies, antagonist administrations (fluamzenil - naloxone).

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High Risk Patients (Ventilation days assessment >3, SAPS II >32).
  • Until 24 h after ICU admission
  • Age > 18 years

Exclusion Criteria:

  • Neurosurgical patients
  • Allergy to medications used in the study
  • CNS diseases (epilepsy, ictus, dementia, anoxic coma…)
  • Liver encephalopathy (Child C)
  • Previous psychiatric or cognitive pathology
  • Absolute contraindications to use enteral route (acceptable NGT, digiunostomy, ileostomy)
  • Pregnant patients or in breast-feeding
  • DNR patients
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360346

Contact: Giovanni Mistraletti, MD +39.339.8245014 giovanni.mistraletti@unimi.it

AO San Paolo - Polo Universitario Recruiting
Milano, Italy, 20142
Contact: Giovanni Mistraletti, MD    +39.339.8245014    giovanni.mistraletti@unimi.it   
Sponsors and Collaborators
University of Milan
Ospedale San Paolo
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Azienda Ospedaliera San Gerardo di Monza
Azienda Ospedaliera Niguarda Cà Granda
Azienda Ospedaliera Fatebenefratelli e Oftalmico
IRCCS Policlinico S. Matteo
San Luigi Gonzaga Hospital
Ospedale S. Giovanni Bosco
Ospedale Cardinal Massaia
Azienda Ospedaliera, Ospedale Civile di Legnano
Nuovo Ospedale Civile S.Agostino Estense
Study Chair: Iapichino Gaetano, MD University of Milan
More Information


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giovanni Mistraletti, University Researcher, University of Milan
ClinicalTrials.gov Identifier: NCT01360346     History of Changes
Other Study ID Numbers: SedaENvsIV
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by Giovanni Mistraletti, University of Milan:
Enteral Sedation
Intravenous Sedation
Critically ill ICU patient
Conscious Sedation
Deep Sedation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents