UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044962
Receipt number R000051372
Scientific Title Association between intravenous amino acid/lipid emulsion and prognosis: a cohort study using medical claims database
Date of disclosure of the study information 2021/07/27
Last modified on 2022/11/08 21:33:49

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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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051372


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name