UMIN-CTR Clinical Trial

Basic information
Public title	Association between intravenous amino acid/lipid emulsion and prognosis: a cohort study using medical claims database
Acronym	Intravenous amino acid/lipid and prognosis
Scientific Title	Association between intravenous amino acid/lipid emulsion and prognosis: a cohort study using medical claims database
Scientific Title:Acronym	Intravenous amino acid/lipid and prognosis
Region	Japan

Condition
Condition	Patients who received parenteral nutrition
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(1) Investigating the association between intravenous amino acid doses and prognosis (2) Investigating the association between intravenous lipid infusion and prognosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-hospital mortality
Key secondary outcomes	(1) Catheter infection (2) Activities of daily living (3) Re-admission (4) Length of stay (5) Medical costs

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	(1) Hospitalized patient (January 2011 to September 2020) (2) Fasting for more than 10 consecutive days
Key exclusion criteria	(1) Surgery (day of hospitalization to 10 days after fasting) (2) Intensive care unit (day of hospitalization to 10 days after fasting) (3) Intravenous mean energy dose <10 kcal/kg (4 to10 days after fasting) (4) Intravenous mean energy dose >=30 kcal/kg(4 to 10 days after fasting) (5) Intravenous mean amino acid dose <0.5 g/kg(4 to 10 days after fasting) * * Only when investigating the association between intravenous lipid and prognosis
Target sample size	100000

Research contact person
Name of lead principal investigator	1st name Kosei Middle name Last name Takagi
Organization	Okayama University Hospital
Division name	The Organ Transplant Center
Zip code	700-0914
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-223-7151
Email	ktakagi@okayama-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Kamoshita
Organization	Otsuka Pharmaceutical Factory, Inc.
Division name	Medical Affairs Department
Zip code	101-0048
Address	2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL	03-5217-5954
Homepage URL
Email	kamoshitas@otsuka.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Biostatistics Center, Kurume University Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	086-235-6938
Email	mae6605@adm.okayama-u.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 07 Month 27 Day

Related information
URL releasing protocol	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051372
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/2072-6643/14/17/3541
Number of participants that the trial has enrolled	295464
Results	Amino acid study Lower prescribed doses of amino acids in parenteral nutrition were associated with higher in-hospital mortality, greater deterioration of ADL, longer hospital LOS, and higher total medical costs for medical inpatients. Lipid study The addition of lipid emulsion to parenteral nutrition in internal medicine inpatients not only improved clinical outcomes but also led to enhanced cost-effectiveness.
Results date posted	2022 Year 11 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Amino acid study Of the 19,602 patients in the Lipid group, 82.6% were 60 years or older, and 58.4% were males; in addition, the most common primary disease was digestive system malignancy in 34.3% patients, followed by digestive system disease in 24.8% patients. Lipid study Of the 86,702 patients, 84.1% were 60 years or older, and 56.1% were males; in addition, the most common primary disease was digestive system malignancy in 26.4% patients, followed by digestive system disease in 22.7% patients.
Participant flow	Amino acid study Of the 295,464 patients aged 18 years or older who were fasting for more than 10 consecutive days during hospitalization, 86,702 patients received parenteral nutrition and so met the inclusion criteria for the study. Lipid study Following the screening of 295,464 medical inpatients, a total of 61,437 patients were eligible for the study. Among all patients, 19,618 (31.9%) were in the Lipid group and 41,819 (68.1%) were in the Non-lipid group. After PSM, 19,602 matched pairs of patients were formed.
Adverse events	Adverse events were not collected in this study.
Outcome measures	Amino acid study Adjusted ORs (95% CI) for in-hospital mortality were 1.20 (1.14-1.26) for the Moderate amino acid group, 1.43 (1.36-1.51) for the Low amino acid group, and 1.72 (1.62-1.82) for the Very low amino acid group, all relative to the Adequate amino acid group. Lipid study The Lipid group had significantly lower incidences than the Non-lipid group of in-hospital mortality (20.3% vs. 26.9%; OR, 0.69; 95%CI, 0.66-0.72; p < 0.001)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 07 Month 27 Day
Date of IRB	2021 Year 07 Month 26 Day
Anticipated trial start date	2021 Year 07 Month 27 Day
Last follow-up date	2021 Year 07 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design A cohort study using the medical claims database Data source A medical database provided by Medical Data Vision Co. Ltd. The database is based on the DPC data/medical and technical service claims data. The database covers about 24% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection. (1) Association between prescribed doses of amino acid and prognosis. Using multivariate logistic regression/ regression analyses, we will examine the association between prognosis among four groups classified by mean amino acid dose. (2) Association between prescribed of lipid and prognosis. Using propensity score matching or multivariate logistic regression/ regression analyses, we will examine the association between lipid infusion and prognosis.

Management information
Registered date	2021 Year 07 Month 27 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051372