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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000030866 |
Receipt No. | R000035241 |
Scientific Title | Efficacy and safety of high-protein early enteral nutrition in critically ill patients with respiratory failure, single-center prospective randomized control trial |
Date of disclosure of the study information | 2018/01/17 |
Last modified on | 2020/07/20 |
Basic information | ||
Public title | Efficacy and safety of high-protein early enteral nutrition in critically ill patients with respiratory failure, single-center prospective randomized control trial | |
Acronym | High-protein enteral nutrition in critically ill patients with respiratory failure | |
Scientific Title | Efficacy and safety of high-protein early enteral nutrition in critically ill patients with respiratory failure, single-center prospective randomized control trial | |
Scientific Title:Acronym | High-protein enteral nutrition in critically ill patients with respiratory failure | |
Region |
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Condition | ||
Condition | critically ill patients requiring mechanical ventilation | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the efficacy and safety of high-protein early enteral nutrition |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | In-hospital mortality |
Key secondary outcomes | Rate of combination parenteral nutrition
Incidence rate of metabolic adverse effects Total insulin dosage Duration of ICU and hospital stay Duration of mechanical ventilation |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | High-protein enteral nutrition for 7 days
(1.2 to 1.5 g/kg/day) |
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Interventions/Control_2 | Standard enteral nutrition for 7 days
(0.6 to 1.2 g/kg/day) |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Critically ill patients with respiratory failure initiating enteral nutrition within 48 hours after admission to intensive care unit | |||
Key exclusion criteria | (1)Patients with unstable hemodynamics requiring repeated increase of noradrenaline dosage
(2)Patients with chronic kidney disease not undergoing dialysis or not planning to undergo dialysis (3)Patients having problems (active gastrointestinal bleeding, ileus or short-bowel syndrome) for administration of enteral nutrition |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hamamatsu medical center | ||||||
Division name | Department of respiratory medicine | ||||||
Zip code | |||||||
Address | 328 Tomitsuka, Naka-ku, Hamamatsu, Shizuoka | ||||||
TEL | 0534537111 | ||||||
shikatarawasagao@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Hamamatsu medical center | ||||||
Division name | Department of respiratory medicine | ||||||
Zip code | |||||||
Address | 328 Tomitsuka, Naka-ku, Hamamatsu, Shizuoka | ||||||
TEL | 0534537111 | ||||||
Homepage URL | |||||||
shikatarawasagao@gmail.com |
Sponsor | |
Institute | Hamamatsu medical center |
Institute | |
Department |
Funding Source | |
Organization | Hamamatsu medical center |
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 | |
Address | |
Tel | |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035241 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |