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UMIN-CTR 臨床試験登録情報の閲覧 |
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 UMIN-CTR ホーム |
用語の説明（簡易版） |
用語の説明（詳細版）--準備中 |
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| 利用者名： | UMIN ID： |
| 試験進捗状況 | 試験中止/Terminated |
| UMIN試験ID | UMIN000034961 |
| 受付番号 | R000039865 |
| 科学的試験名 | |
| 一般公開日（本登録希望日） | 2019/02/01 |
| 最終更新日 | 2018/11/21 |
| 基本情報/Basic information | |||
| 一般向け試験名/Public title | Fenoldopam improves urine output in oliguric critically surgical patients, Observational | ||
| 一般向け試験名略称/Acronym | Fenoldopam improves urine output in oliguric critically surgical patients, Observational | ||
| 科学的試験名/Scientific Title | Fenoldopam improves urine output in oliguric critically surgical patients, Observational | ||
| 科学的試験名略称/Scientific Title:Acronym | Fenoldopam improves urine output in oliguric critically surgical patients, Observational | ||
| 試験実施地域/Region |
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| 対象疾患/Condition | ||||||||
| 対象疾患名/Condition | Intensive care unit | |||||||
| 疾患区分1/Classification by specialty |
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| 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 | : Fenoldopam is a short acting dopamine A1 receptor agonist which mediates vasodilation of the renal arteries thereby increasing renal blood flow, creatinine clearance, urinary flow and excretion of sodium. The objectives of this study were to determine whether low-dose fenoldopam or low-dose fenoldopam + a diuretic improve urine output in acute renal failure patients providing a positive effect preventing fluid accumulation and also verify the renoprotective effect of fenoldopam in ICU. | |
| 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 | ||
| 試験の性質2/Trial characteristics_2 | ||
| 試験のフェーズ/Developmental phase | ||
| 評価/Assessment | ||
| 主要アウトカム評価項目/Primary outcomes | The objectives of this study were to determine whether low-dose fenoldopam or low-dose fenoldopam + a diuretic improve urine output in acute renal failure | |
| 副次アウトカム評価項目/Key secondary outcomes | ||
| 基本事項/Base | ||
| 試験の種類/Study type | 観察/Observational | |
| 試験デザイン/Study design | ||
| 基本デザイン/Basic design | ||
| ランダム化/Randomization | ||
| ランダム化の単位/Randomization unit | ||
| ブラインド化/Blinding | ||
| コントロール/Control | ||
| 層別化/Stratification | ||
| 動的割付/Dynamic allocation | ||
| 試験実施施設の考慮/Institution consideration | ||
| ブロック化/Blocking | ||
| 割付コードを知る方法/Concealment | ||
| 介入/Intervention | ||
| 群数/No. of arms | ||
| 介入の目的/Purpose of intervention | ||
| 介入の種類/Type of intervention | ||
| 介入1/Interventions/Control_1 | ||
| 介入2/Interventions/Control_2 | ||
| 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 |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender | 男/Male | ||||
| 選択基準/Key inclusion criteria | Patient selection criteria were, those who do not have CKD and which urine output was <500 milliliters in the last 6hrs period and consequently fulfill the criteria for acute renal injury (AKI) by the 2004 RIFLE (Table Rifle Criteria) | ||||
| 除外基準/Key exclusion criteria | Patient selection criteria were, those who do not have CKD and which urine output was <500 milliliters in the last 6hrs period and consequently fulfill the criteria for acute renal injury (AKI) by the 2004 RIFLE (Table Rifle Criteria). | ||||
| 目標参加者数/Target sample size | 126 | ||||
| 責任研究者/Research contact person | ||||||||||||||
| 責任研究者/Name of lead principal investigator |
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| 所属組織/Organization | Northwell Health System | |||||||||||||
| 所属部署/Division name | Intensive unit care | |||||||||||||
| 郵便番号/Zip code | ||||||||||||||
| 住所/Address | 27005 76th Ave, Queens, NY 11040 | |||||||||||||
| 電話/TEL | +17184703000 | |||||||||||||
| Email/Email | RBarrera@northwell.edu | |||||||||||||
| 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 |
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| 組織名/Organization | Northwell | |||||||||||||
| 部署名/Division name | Intensive care unit | |||||||||||||
| 郵便番号/Zip code | ||||||||||||||
| 住所/Address | 461 West, 150th St | |||||||||||||
| 電話/TEL | +15165908262 | |||||||||||||
| 試験のホームページURL/Homepage URL | ||||||||||||||
| Email/Email | jcagliani@northwell.edu | |||||||||||||
| 実施責任組織/Sponsor | ||
| 機関名/Institute | その他 | IRB |
| 機関名/Institute （機関選択不可の場合） |
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| 部署名/Department | ||
| 研究費提供組織/Funding Source | ||
| 機関名/Organization | その他 | No funding |
| 機関名/Organization （機関選択不可の場合） |
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| 組織名/Division | ||
| 組織の区分/Category of Funding Organization | その他/Other | |
| 研究費拠出国/Nationality of Funding Organization | ||
| 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 | ||
| 住所/Address | ||
| 電話/Tel | ||
| Email/Email | ||
| 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 | Northwell health System | |
| 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 |
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| 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 | ||
| 主な結果/Results | Of the 126 patients, who met inclusion criteria, 87 patients received fenoldopam (0.03mcg/kg/min) alone and 39 patients received fenoldopam plus a diuretic in the first 24 hours (Image 1). Fenoldopam alone, significantly increased mean urine output to 1376ml in 24 hours, from an assumed baseline mean of 1000ml/24h (P=0.005). (Image 3). Fenoldopam plus diuretic also demonstrated an increase in mean urine output (1525 ml) in the first 24 hours (P=0.02). (Image 4). There was no statistically significant difference when fenoldopam was compared to fenoldopam plus a diuretic (p= 0.5). There was also no significant change in creatinine clearance from baseline in either group Mann-Whitney test p value=0.88 and p value=0.7 (Image 5, 6, and table 2). In terms of fluid accumulation, there is no significant change adding diuretics p value=0.92. 59% of patients with fenoldopam and 53%with fenoldopam+diuretics progressed to Injury/Fail. | |
| 主な結果入力日/Results date posted | ||
| 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 | 試験中止/Terminated | |||||||
| プロトコル確定日/Date of protocol fixation |
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| 倫理委員会による承認日/Date of IRB | ||||||||
| 登録・組入れ開始（予定）日/Anticipated trial start date |
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| フォロー終了(予定)日/Last follow-up date | ||||||||
| 入力終了(予定)日/Date of closure to data entry | ||||||||
| 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 | Observational | |
| 管理情報/Management information | ||||||||
| 登録日時/Registered date |
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| 最終更新日/Last modified on |
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| 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=R000039865 |
| URL(英語) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039865 |
| 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 |
