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

This study is currently recruiting participants.
Verified April 2012 by University of Milan
Sponsor:
Collaborators:
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
AO Cardinal Massaia, Asti
AO Ospedale Civile, Legnano (MI)
AO Ospedale Civile, Desio (MI)
Nuovo Ospedale Civile S.Agostino Estense
Information provided by (Responsible Party):
Giovanni Mistraletti, University of Milan
ClinicalTrials.gov Identifier:
NCT01360346
First received: May 20, 2011
Last updated: April 23, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Critical Illness
Mechanical Ventilation Complication
 Procedure: Enteral Sedation (EN)
Procedure: Control group: Intravenous Sedation (IV)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multicentric, Single Blind, Randomized Controlled Trial on Enteral Sedation Versus Intravenous Sedation in Critically Ill High-risk ICU Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Percent of efficacy, measured by observed RASS = desired RASS ± 1. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sedation protocol effectiveness: percentage of "protocol violation days" on the total of ICU days. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Ventilation free days (12) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Nursing evaluation of sedation adequacy (communication skills, cooperation, environment tolerance) (13) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Overall ICU and hospital mortality, absolute mortality after 1 year from ICU discharge. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Sedative drugs costs. [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Indirect inefficacy markers [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: INTRAVENOUS

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360346

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

Locations
Italy
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
AO Cardinal Massaia, Asti
AO Ospedale Civile, Legnano (MI)
AO Ospedale Civile, Desio (MI)
Nuovo Ospedale Civile S.Agostino Estense
Investigators
Study Chair: Iapichino Gaetano, MD University of Milan
  More Information

Publications:

Responsible Party: Giovanni Mistraletti, University Researcher, University of Milan
ClinicalTrials.gov Identifier: NCT01360346     History of Changes
Other Study ID Numbers: SedaENvsIV
Study First Received: May 20, 2011
Last Updated: April 23, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
Enteral Sedation
Intravenous Sedation
Critically ill ICU patient
Conscious Sedation
Deep Sedation
RASS
CAM-ICU
 VNR
BPS
Propofol
Midazolam
Hydroxyzine
Lorazepam
Melatonin

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Midazolam
Lorazepam
Propofol
Melatonin
Hydroxyzine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on June 18, 2013