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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000035295
受付番号 R000040213
科学的試験名
一般公開日(本登録希望日) 2018/12/30
最終更新日 2019/06/18

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis
一般向け試験名略称/Acronym
Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis
科学的試験名/Scientific Title
Choice Of Initial Resuscitating Fluids In The Outcome Of Acute Pancreatitis
科学的試験名略称/Scientific Title:Acronym
Fluids in Acute pancreatitis
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Acute Pancreatitis
疾患区分1/Classification by specialty
消化器内科学(消化管)/Gastroenterology 消化器内科学(肝・胆・膵)/Hepato-biliary-pancreatic medicine
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To see the effect on outcome of acute pancreatitis using Ringers lactate vs Normal saline
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
To evaluate the effect of initial resuscitation with Ringers Lactate versus Normal Saline on the outcome of acute pancreatitis
副次アウトカム評価項目/Key secondary outcomes
1. To analyze the difference in CRP in two groups as marker of systemic inflammation.
2. To analyze the difference in SIRS in two groups as marker of systemic inflammation.
3. To analyze the incidence of severity of diseases in both the groups as per the revised Atlanta classification.
4. To analyze the difference in complications of acute pancreatitis in both the groups.
5. To analyze the difference in length of hospital stay in both the groups

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1
All the patients who presented to the ER of Bir Hospital and diagnosed as acute pancreatitis using the Atlanta classification will be subjected to fluid resuscitation using Ringer lactate 10 ml/kg of the study fluid in 60 minutes immediately after randomization, and then 1.5 ml/kg/hour of the study fluid for three days. All patients will receive additional 1 liter of 5% dextrose per 24 hours. The amount of daily fluid administered were as per the standard guideline which is 250-400 ml per hour.
介入2/Interventions/Control_2
All the patients who presented to the ER of Bir Hospital and diagnosed as acute pancreatitis using the Atlanta classification will be subjected to fluid resuscitation using NS 10 ml/kg of the study fluid in 60 minutes immediately after randomization, and then 1.5 ml/kg/hour of the study fluid for three days. All patients will receive additional 1 liter of 5% dextrose per 24 hours. The amount of daily fluid administered were as per the standard guideline which is 250-400 ml per hour.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
65 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
All patients diagnosed with acute pancreatitis presenting in emergency (ER) of Bir hospital
除外基準/Key exclusion criteria
1. Patients below 18 yrs
2. Patients with co-morbid illness like chronic heart failure, chronic kidney disease.
3. Patients presenting to hospital for more than 48 hrs of symptoms or any transferred case from other hospital who are already resuscitated.
4. Patients with chronic obstructive pulmonary disease with requirement for home oxygen
目標参加者数/Target sample size 38

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Binod
ミドルネーム
Karki
所属組織/Organization
Bir Hospital
National Academy of Medical Sciences
所属部署/Division name
Gastroenterology
郵便番号/Zip code 44600
住所/Address
Mahabaudhha, Kathmandu, Nepal.
電話/TEL 009779851152447
Email/Email binodkarki@yahoo.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Binod
ミドルネーム
Karki
組織名/Organization
Bir Hospital National Academy of Medical sciences
部署名/Division name
Gastroenterology
郵便番号/Zip code 44600
住所/Address
Mahabaudhha, Kathmandu, Nepal.
電話/TEL 009779851152447
試験のホームページURL/Homepage URL http://www.nams.org.np
Email/Email binodkarki@yahoo.com

実施責任組織/Sponsor
機関名/Institute その他 Bir Hospital National Academy of Medical sciences
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Bir Hospital National Academy of Medical sciences
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 地方自治体/Local Government
研究費拠出国/Nationality of Funding Organization
Nepalese

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
National Academy of Medical Sciences
住所/Address
Bir Hospital, Mahabaudhha, Kathmandu
電話/Tel +977-1-4230710
Email/Email admin@nams.org.np

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2018 12 30

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 51
主な結果/Results
26 participants in Ringer Lactate group and 25 in Normal saline group. Baseline characteristic and lab parameters were comparable in both the groups. SIRS and CRP were significantly less in RL group compared to NS group during treatment.
主な結果入力日/Results date posted
2019 06 18
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2018 01 01
倫理委員会による承認日/Date of IRB
2018 10 01
登録・組入れ開始(予定)日/Anticipated trial start date
2018 01 02
フォロー終了(予定)日/Last follow-up date
2019 05 30
入力終了(予定)日/Date of closure to data entry
2019 05 30
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 12 18
最終更新日/Last modified on
2019 06 18


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040213
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040213

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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