UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045966 |
|---|---|
| Receipt number | R000052467 |
| Scientific Title | Carbon dioxide production and oxygen uptake evaluated by indirect calorimetry in mechanically ventilated patients with sepsis |
| Date of disclosure of the study information | 2021/11/04 |
| Last modified on | 2021/11/03 02:50:14 |
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Basic information
Public title
Evaluation of carbon dioxide production and oxygen demand using indirect calorimetry in patients with sepsis
Acronym
Indirect calorimetry in sepsis
Scientific Title
Carbon dioxide production and oxygen uptake evaluated by indirect calorimetry in mechanically ventilated patients with sepsis
Scientific Title:Acronym
Indirect calorimetry in sepsis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measured the VCO2 and VO2 in mechanically ventilated patients with sepsis and evaluated whether these parameters are associated with survival.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day survival
Key secondary outcomes
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
Adult patients with sepsis who required mechanical ventilation in the intensive care unit (ICU) were enrolled. Sepsis was diagnosed according to Sepsis-3.
Key exclusion criteria
Following patients were excluded because of the inaccuracy of indirect calorimetry (IC) measurement: patients complicated with pneumothorax, those treated with extracorporeal membrane oxygenation (ECMO) therapy, those ventilated with more than 85% fraction of inspired oxygen (FIO2), those with changes in ventilator settings during IC measurement, those intubated from nasal or tracheostomy, and those isolated for high risk of airborne infection. Moreover, we excluded patients who declared do not attempt resuscitation (DNAR) and those without informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kent |
| Middle name | |
| Last name | Doi |
Organization
The University of Tokyo
Division name
Department of Emergency and Critical Care Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kentdoi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Hirayama |
Organization
The University of Tokyo
Division name
Department of Emergency and Critical Care Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
ichirohirayama1983@gmail.com
Sponsor or person
Institute
The University of Tokyo, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 04 | 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
55
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Inclusion criteria:
Adult patients with sepsis who required mechanical ventilation in the intensive care unit (ICU) were enrolled.
Primary outcome:
28-day survival
Management information
Registered date
| 2021 | Year | 11 | Month | 03 | Day |
Last modified on
| 2021 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052467
