UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033508 |
|---|---|
| Receipt number | 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 | 2023/01/27 09:30:08 |
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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
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
t_oshima@chiba-u.jp
Sponsor or person
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
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038209
