UMIN-CTR Clinical Trial

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
Email	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
Email	ichirohirayama1983@gmail.com

Sponsor
Institute	The University of Tokyo, Department of Emergency and Critical Care Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052467