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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033508
Receipt No. R000038209
Scientific Title Clinical evaluation of the ease of use of a new indirect calorimeter for energy expenditure measurement in ICU patients: The ICALIC international multicentric study
Date of disclosure of the study information 2018/07/25
Last modified on 2018/07/25

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Basic information
Public title Clinical evaluation of the ease of use of a new indirect calorimeter for energy expenditure measurement in ICU patients: The ICALIC international multicentric study
Acronym The ICALIC Study
Scientific Title Clinical evaluation of the ease of use of a new indirect calorimeter for energy expenditure measurement in ICU patients: The ICALIC international multicentric study
Scientific Title:Acronym The ICALIC Study
Region
Japan Europe

Condition
Condition Mechanically ventilated adult (age over 18 years old) ICU patients
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study aims at evaluating the ease of application of the new calorimeter in mechanically ventilated ICU patients, as well as the stability and the feasibility of the measurements across clinically relevant situations such as the use of different types of ventilators, various ranges of oxygen and airway pressure support, sedation and consciousness levels, and patient severity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time needed to start IC measurement in Q-NRG compared to currently used calorimeters
Key secondary outcomes 1. Comparison of EE from Q-NRG and currently used calorimeters
2. Coefficient of variation (CV) of EE for different mechanical ventilators
3. CV of EE when using different ventilation modes
4. CV of EE in various ranges of oxygen and airway pressure support
5. CV of EE when measured in different sedation/consciousness levels
6. CV of EE when measured in different levels of patient severity

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Mechanically ventilated adult (age over 18 years old) ICU patients
Key exclusion criteria 1) Fraction of inhaled oxygen (FIO2) > 70%
2) Positive end expiratory pressure (PEEP) >10cmH2O
3) Peak ventilatory pressure > 30cmH20
4) Presence of air leaks from thoracic drain tube
5) Changes in vasoactive agent dose (>20%, <1 hr before and/or during IC)
6) Agitation or change in sedative dose (>20%, <1 hr before and/or during IC)
7) Change in body temperature (>0.5 C, <1 hr before and/or during IC)
8) Expected duration of ICU stay < 24 hours
9) Expected survival of the patient < 24 hours
Target sample size 49

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ODA, Shigeto
Organization Chiba University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL 043-226-2341
Email odas@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Oshima
Organization Chiba University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL 043-226-2341
Homepage URL
Email t_oshima@chiba-u.jp

Sponsor
Institute Claude Pichard, MD, PhD
Representative of the Geneva University Hospital
Rue Gabrielle-Perret-Gentil 4 - 1211 Geneva 14, Switzerland, Phone: +41 22 372 9345
Institute
Department

Funding Source
Organization European Society for Intensive Care Medicine (ESICM)
European Society for Clinical Nutrition and Metabolism (ESPEN)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02796430
Org. issuing International ID_1 Clinicaltrials.gov
Study ID_2 PB_2016-02546; 2016-MD-0031; CIV-16-12-017904
Org. issuing International ID_2 Swissethics; Swissmedic; EUDAMED
IND to MHLW

Institutions
Institutions ジュネーブ大学病院(スイス・ジュネーブ)、ローザンヌ大学病院(スイス・ローザンヌ)、ウィーン大学病院(オーストリア・ウィーン)、ラビン・メディカルセンター(テルアビブ・イスラエル)、カロリンスカ大学病院(ストックホルム・スウェーデン)、ブリュッセル大学病院(ブリュッセル・ベルギー)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 07 Month 25 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038209

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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