Unique ID issued by UMIN | UMIN000005609 |
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Receipt number | R000006628 |
Scientific Title | Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition |
Date of disclosure of the study information | 2011/05/16 |
Last modified on | 2019/11/28 12:48:47 |
Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition
Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition
Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition
Prevention of gastrointestinal complications by infusion pump in patients receiving enteral nutrition
Japan |
Inpatients receiving enteral nutrition via nasogastric tube, gastric fistula, or intestinal fistula
Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Cardiology | Pneumology | Endocrinology and Metabolism |
Nephrology | Neurology | Clinical immunology |
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Chest surgery | Endocrine surgery | Oto-rhino-laryngology |
Orthopedics | Urology | Neurosurgery |
Cardiovascular surgery |
Others
NO
To clarify the preventive effect of the use of gastrointestinal nutrient pump on gastrointestinal complications.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
[BLOOD] labo data (on the registration, two weeks after, and at the end of the study)
Blood chemistry: TP, ALB, BUN, CRE, CHE, T-CHO, TG, Na, Cl, K, GLU
General blood count: WBC, RBC, Hb, Ht, SEG, LYMPH
[URINE] labo data (on the registration, two weeks after, and at the end of the study)
Specific gravity
[OBSERVATION] items
Defecation situation (with Bristol scale)
Weight and frequency of defecation
Frequency of abdominal pain, nausea, and vomiting
Presence of pressure ulcers, the presence of diaper rash, body weight, catheter problems, and choking
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Device,equipment |
Nutrition pump group
Naturally dropped group
20 | years-old | <= |
90 | years-old | >= |
Male and Female
Inpatients aged from 20 to 90 years receiving enteral nutrition via nasogastric tube, gastric fistula, or intestinal fistula
1. CD toxin positive
2.Patient with diarrhea by antibiotic or other medicines such as laxative
3.Patient taking:
The semisolid preparation, K2-S, K-LEC, enteral nutrition containing more than 1.7 g/100 kcal of dietary fiber or 1 kcal/mL of calories.
4.Patient with impaired gastrointestinal absorption due to diseases (short bowel syndrome and inflammatory bowel disease)
5.Patient with impaired gastrointestinal motility due to disease
6.Patient with aspiration pneumonia
7. Severely ill patient with multiple (>2) organ failure
8.Patient with severe diarrhea
9.Patient with fatty diarrhea
10.Patient with lactose intolerance
11.Patient not recommended to be registered by physician
200
1st name | Yuko |
Middle name | |
Last name | Okuyama |
Toho University Ohashi Medical Center
Pharmaceutical department
1530085
2-22-36 Ohashi, Meguro-ku Tokyo
03-3468-1251
ph-youka@oha.toho-u.ac.jp
1st name | Yuko |
Middle name | |
Last name | Okuyama |
Toho University Ohashi Medical Center
Pharmaceutical department
1530085
2-22-36 Ohashi, Meguro-ku Tokyo
03-3468-1251
ph-youka@oha.toho-u.ac.jp
Division of Clinical pharmacokinetics, Faculty of Pharmacy, Keio University
None
Self funding
The clover hospital
Nishigunma national hospital
Toho University Medical center Omori hospital
Showa University Fujigaoka hospital
Toho University Ohashi Medical Center
2-22-36 Ohashi, Meguro-ku Tokyo
03-3468-1251
secretary@oha.toho-u.ac.jp
NO
クローバーホスピタル(神奈川県)、西群馬病院(群馬県)、東邦大学医療センター大森病院(東京都)、昭和大学藤が丘病院 (神奈川県)、東邦大学医療センター大橋病院(東京都)
2011 | Year | 05 | Month | 16 | Day |
Unpublished
Open public recruiting
2011 | Year | 03 | Month | 02 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 16 | Day |
2019 | Year | 11 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006628
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