敗血症における血行力学的蘇生のための制限または自由輸液 (FRESHLY)
低血圧メタ分析（FRESHLY）を伴う敗血症における輸液制限蘇生：ARISE FLUIDS、CLASSIC、CLOVERS、およびEVIS試験の個々の患者データMet分析
A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
調査の概要
詳細な説明
This study is a prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
The investigators will include four multicentre, open-label, randomised, clinical trials:
- Australasian Resuscitation in Sepsis Evaluation Fluids of Vasopressors in Emergency Department Sepsis (ARISE FLUIDS) trial conducted in Australia and New Zealand. ClinicalTrials.gov identifier NCT04569942
- Conservative versus Liberal Approach to fluid therapy of Septic Shock in intensive Care (CLASSIC) trial conducted in seven European countries. ClinicalTrials.gov identifier NCT03668236
- Crystalloid Liberal or Vasopressors Early (CLOVERS) trial conducted in the United States. ClinicalTrials.gov identifier NCT03434028
- Early Vasopressors in Sepsis (EVIS) trial conducted in the United Kingdom. ClinicalTrials.gov identifier NCT05179499
All four trials have all received relevant approval from a research ethics committee with a locally appropriate method of obtaining consent. These trials are prospectively chosen prior to the results of any individual trial being known because they are investigating the same broad question in patients with acute septic shock across several countries. The investigators of these trials collaborated to harmonise data and outcomes as far as possible across all trials to facilitate an IPDMA.
The aims to provide high level evidence to address the question of whether a fluid sparing/early vasopressor approach or a liberal fluid/later vasopressor approach to initial haemodynamic resuscitation in septic shock results in improved outcomes, including mortality.
研究の種類
入学 (推定)
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
サンプリング方法
調査対象母集団
All trials include adult patients requiring resuscitation for hypotension or hypoperfusion due to suspected sepsis as defined in the original studies. Participants may be enrolled in the emergency department, acute care ward or intensive care unit.
説明
Inclusion Criteria:
Participants of the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials who had:
- Suspected or proven infection
- Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg
- Lactate ≥ 2.0 mmol/L
- Requirement for vasopressors to meet perfusion targets
Exclusion criteria:
Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials
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
- 観測モデル：OTHER
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Vasopressors
A haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets |
A haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets |
|
Fluids
A strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required. |
A strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required. |
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 |
|---|---|---|
|
All-cause mortality at 90 days post randomisation
時間枠：90 days
|
Death from any cause at 90 days after randomisation |
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time from randomisation to death
時間枠：Up to day 90
|
Time from randomisation to death |
Up to day 90
|
|
Incidence of mechanical ventilation
時間枠：from randomisation until day 90 post-randomisation
|
Commencement of mechanical ventilation from randomisation until day 90 post-randomisation |
from randomisation until day 90 post-randomisation
|
|
Incidence of acute renal replacement therapy
時間枠：from randomisation until day 90 post-randomisation
|
Commencement of renal replacement therapy from randomisation until day 90 post-randomisation |
from randomisation until day 90 post-randomisation
|
|
Days alive free of organ support at 28 days post randomisation
時間枠：from randomisation until day 28 post-randomisation
|
days the patient is alive and receiving nil organ support from from randomisation until day 28 post-randomisation |
from randomisation until day 28 post-randomisation
|
|
Duration of hospital stay
時間枠：From randomisation until day 90 post-randomisation
|
Length of time in hospital from randomisation until death or hospital discharge or day 90 post-randomisation |
From randomisation until day 90 post-randomisation
|
|
Incidence of serious adverse events
時間枠：from randomisation until day 90 post-randomisation
|
Number of adverse events from randomisation until day 90 post-randomisation |
from randomisation until day 90 post-randomisation
|
|
Duration of intensive care unit (ICU) stay
時間枠：From randomisation until day 90 post-randomisation
|
Length of time in ICU from randomisation until death or hospital discharge or day 90 post-randomisation |
From randomisation until day 90 post-randomisation
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。