Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients (REFACED Sepsis)
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)
調査の概要
詳細な説明
BACKGROUND:
Sepsis is common in emergency department (ED) patients. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines, but there are no recommendations for sepsis without hypotension or shock. Studies in septic shock seem to favour fluid restriction. Whether this is true in sepsis without hypotension/shock is unknown.
OBJECTIVES:
The aim of the REFACED Sepsis trial is to test if an IV fluid restrictive protocol in ED patients with sepsis is feasible, i.e., if the protocol decreases the IV fluid volumes administered.
DESIGN:
REFACED Sepsis is a multicenter, randomized, parallel-group, open-labeled, feasibility trial
POPULATION:
ED patients with sepsis expected to be admitted for ≥ 24 hours
EXPERIMENTAL INTERVENTION:
In the IV fluid restriction group no IV fluids should be given unless one of the below mentioned occurs;
A fluid bolus of 250 ml isotonic crystalloid may be given within 15 minutes if one of the following occurs (hypoperfusion criteria):
- Lactate concentration ≥ 4 mmol/l (arterial or venous blood gas/blood sample)
- Hypotension (systolic BP < 90 mmHg)
- Mottling beyond edge of kneecap (i.e., Mottling score >2)53
- Severe oliguria, i.e., diuresis < 0.1 ml/kg/h, during the first 4 hours of admission
All patients will be ensured min. 1 L of oral/intravenous fluids in 24 hours and electrolytes can be corrected.
CONTROL INTERVENTION:
In the usual care group there will be no upper limit for the use of IV fluids.
OUTCOMES:
The primary outcome is 24-hour intravenous crystalloid fluid administration. Key secondary outcomes are: Feasibility measures: Number of patients with major protocol violations, Number of patients screened vs included, Time from admission to inclusion, Number of patients lost to follow up in terms of 24-hour fluids, Accumulated serious adverse reactions and events (SAEs + Suspected Unexpected Serious Adverse Reaction (SUSARs)) within 48 hours in-hospital, Total fluids (oral and intravenous) at 24 hours,
TRIAL-SIZE:
124 patients will be randomized to restrictive fluid administration or usual care within 24 hours of randomization
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
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Central Denmark Region
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Aarhus、Central Denmark Region、デンマーク、8200
- Department of Emergency Medicine, Aarhus University Hospital
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Randers、Central Denmark Region、デンマーク、8930
- Department of Emergency Medicine, Regional Hospital Randers
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Viborg、Central Denmark Region、デンマーク、8800
- Department of Emergency Medicine, Regional Hospital Viborg
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria: All of the below must be fulfilled:
- Unplanned emergency department admission
- Age ≥ 18 years
Sepsis defined as
- suspected infection by the treating clinician AND
- blood cultures drawn AND
- IV antibiotics administered or planned AND
- An infection related increase of SOFA*-score ≥ 2 from baseline
Expected hospital stay > 24 hours as deemed by treating clinician
- Sequential Organ Failure Assessment (SOFA) Score
Further more the patient must fulfill criteria for enrollment in an acute study according to Danish law
Exclusion Criteria: We will exclude patients fulfilling any of following exclusion criteria:
- ≥ 500 ml of fluids given prior to randomization
- Invasively ventilated or vasopressors initiated at the time of screening
- Known or suspected severe bleeding judged by the treating clinician
- Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
- Prior enrollment in the trial
- Patients, who the clinician expect not to survive the next 24-hours
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Restrictive fluid administration
No IV fluids unless one of the extenuating circumstances occur;
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Types of fluids in both intervention groups:
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アクティブコンパレータ:Usual care (standard care)
There will be no upper limit for the use of either IV or oral/enteral fluids
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Types of fluids in both intervention groups:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
24-hour crystalloid iv. fluids
時間枠:24 hours from randomization
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total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization
|
24 hours from randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Protocol violations
時間枠:24 hours from randomization
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Feasibility measure: Number of patients with major protocol violations
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24 hours from randomization
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Screened-vs.-randomized-ratio
時間枠:Through study completion, an average of 1 year
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Feasibility measure: Number of patients screened vs included
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Through study completion, an average of 1 year
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Time to inclusion
時間枠:Through study completion, an average of 1 year
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Feasibility measure: Time from admission to inclusion/randomization (hours)
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Through study completion, an average of 1 year
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Lost-to-follow-up-rate
時間枠:24 hours from randomization
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Feasibility measure: Number of patients lost to follow up in terms of 24-hour fluids
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24 hours from randomization
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Accumulated serious adverse reactions (SARs + SUSARs)
時間枠:7 days from randomization
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Feasibility measure: Accumulated serious adverse reactions and events (SAEs + SARs+ SUSARs) within 7 days in-hospital
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7 days from randomization
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Total 24-hour fluids
時間枠:24 hours from randomization
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Total fluids (oral and intravenous) at 24 hours
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24 hours from randomization
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Mortality
時間枠:Total of 90-days
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In-hospital, 30- and 90-days mortality
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Total of 90-days
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協力者と研究者
協力者
捜査官
- 主任研究者:Marie K Jessen, MD、Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Denmark
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RECEM0001
- 2021-000224-35 (EudraCT番号)
- 1-10-72-163-21 (その他の識別子:The Committee on Health Research Ethics, Central Denmark Region)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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