Unique ID issued by UMIN | UMIN000044962 |
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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 |
Association between intravenous amino acid/lipid emulsion and prognosis: a cohort study using medical claims database
Intravenous amino acid/lipid and prognosis
Association between intravenous amino acid/lipid emulsion and prognosis: a cohort study using medical claims database
Intravenous amino acid/lipid and prognosis
Japan |
Patients who received parenteral nutrition
Medicine in general |
Malignancy
NO
(1) Investigating the association between intravenous amino acid
doses and prognosis
(2) Investigating the association between intravenous lipid infusion
and prognosis
Efficacy
In-hospital mortality
(1) Catheter infection
(2) Activities of daily living
(3) Re-admission
(4) Length of stay
(5) Medical costs
Observational
18 | years-old | <= |
Not applicable |
Male and Female
(1) Hospitalized patient (January 2011 to September 2020)
(2) Fasting for more than 10 consecutive days
(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
100000
1st name | Kosei |
Middle name | |
Last name | Takagi |
Okayama University Hospital
The Organ Transplant Center
700-0914
2-5-1 Shikata-cho, Kita-ku, Okayama
086-223-7151
ktakagi@okayama-u.ac.jp
1st name | Satoru |
Middle name | |
Last name | Kamoshita |
Otsuka Pharmaceutical Factory, Inc.
Medical Affairs Department
101-0048
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
03-5217-5954
kamoshitas@otsuka.jp
Okayama University Hospital
Otsuka Pharmaceutical Factory, Inc.
Profit organization
Japan
Biostatistics Center, Kurume University Graduate School of Medicine
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
2-5-1 Shikata-cho, Kita-ku, Okayama
086-235-6938
mae6605@adm.okayama-u.ac.jp
NO
2021 | Year | 07 | Month | 27 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051372
Published
https://www.mdpi.com/2072-6643/14/17/3541
295464
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.
2022 | Year | 11 | Month | 08 | Day |
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.
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 were not collected in this study.
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)
Main results already published
2021 | Year | 07 | Month | 27 | Day |
2021 | Year | 07 | Month | 26 | Day |
2021 | Year | 07 | Month | 27 | Day |
2021 | Year | 07 | Month | 27 | Day |
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.
2021 | Year | 07 | Month | 27 | Day |
2022 | Year | 11 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051372
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