Use of Oxiris Filter in Septic Shock Patients Requiring Renal Replacement Therapy: A Retrospective Cohort Study
Impact of Oxiris Filter Use on Mortality and Renal Outcomes in Critically Ill Patients With Septic Shock Requiring Renal Replacement Therapy: A Retrospective Cohort Study
調査の概要
詳細な説明
Sepsis and septic shock are leading causes of morbidity and mortality in critically ill patients and are commonly associated with acute kidney injury requiring renal replacement therapy (RRT). Extracorporeal blood purification techniques have been proposed as an adjunctive therapy to modulate the host inflammatory response. The Oxiris filter is a modified AN69-based membrane designed to provide renal support while simultaneously adsorbing endotoxins and cytokines.
This retrospective cohort study aims to assess the impact of Oxiris filter use on clinical outcomes in patients with septic shock requiring RRT. The study will include adult patients admitted to an intensive care unit over a defined study period who required RRT due to acute kidney injury in the context of septic shock.
Patients will be categorized according to the type of hemofilter used (Oxiris versus standard filters). The primary outcome will be mortality within a defined follow-up period. Secondary outcomes will include renal recovery, duration of renal replacement therapy, and length of stay in the intensive care unit.
Statistical analyses will be performed to compare outcomes between groups and adjust for potential confounding factors. Appropriate multivariable models will be used to evaluate the association between Oxiris use and clinical outcomes.
Given the retrospective nature of the study, no interventions will be assigned, and all treatments will have been administered according to routine clinical practice.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Navarre
-
Pamplona、Navarre、スペイン、31008
- Clinica Universidad de Navarra
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adult patients (≥18 years old)
- Admission to the intensive care unit
- Diagnosis of septic shock
- Requirement of renal replacement therapy due to acute kidney injury
- Treatment with either Oxiris filter or standard hemofilters
Exclusion Criteria:
- Patients under 18 years of age
- Chronic dialysis prior to ICU admission
- Missing key clinical data
- Patients not meeting criteria for septic shock
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Oxiris Group
Patients with septic shock requiring renal replacement therapy treated with the Oxiris filter.
|
Hemofilter used for renal replacement therapy with cytokine and endotoxin adsorption properties.
|
|
Standard Filter Group
Patients with septic shock requiring renal replacement therapy treated with standard hemofilters.
|
Standard hemofilters used for continuous renal replacement therapy without specific adsorption properties for endotoxins or cytokines.
These filters provide conventional renal support and are used according to routine clinical practice.
|
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 |
|---|---|---|
|
28-day all-cause mortality
時間枠:Up to 28 days
|
All-cause mortality within 28 days from the initiation of renal replacement therapy.
|
Up to 28 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ICU length of stay
時間枠:From ICU admission to ICU discharge, assessed up to 28 days
|
Length of stay in the intensive care unit measured in days.
|
From ICU admission to ICU discharge, assessed up to 28 days
|
|
Renal recovery
時間枠:Assessed at hospital discharge, up to 90 days
|
Recovery of kidney function defined as independence from renal replacement therapy at discharge.
|
Assessed at hospital discharge, up to 90 days
|
|
Duration of renal replacement therapy
時間枠:From initiation to discontinuation of RRT, assessed up to 28 days
|
Total duration of renal replacement therapy during ICU stay, measured in days.
|
From initiation to discontinuation of RRT, assessed up to 28 days
|
|
In-hospital mortality
時間枠:From hospital admission to discharge, assessed up to 90 days
|
All-cause mortality during hospital stay.
|
From hospital admission to discharge, assessed up to 90 days
|
協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- OXIRIS
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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