N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
Adjunctive N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis: A Randomized Controlled Trial
Spontaneous bacterial peritonitis (SBP) is one of the most serious infectious complications of liver cirrhosis and ascites. It affects approximately 10-30% of hospitalized patients with decompensated cirrhosis and carries an in-hospital mortality of 20-40% despite appropriate antimicrobial therapy. SBP results from bacterial translocation across the intestinal mucosa together with cirrhosis-associated immune dysfunction, leading to impaired bacterial clearance and exaggerated systemic inflammation. Current international guidelines recommend immediate empirical antibiotic therapy together with intravenous human albumin to reduce the incidence of acute kidney injury (AKI), hepatorenal syndrome, and mortality.
Although this strategy has substantially improved outcomes, treatment failure, persistent infection, renal dysfunction, acute-on-chronic liver failure (ACLF), and early mortality remain common, indicating that currently available therapy does not adequately address all pathogenic mechanisms of SBP. Increasing evidence suggests that oxidative stress is a central contributor to the progression of bacterial infections in cirrhosis. Excessive production of reactive oxygen species aggravates hepatocellular injury, endothelial dysfunction, immune dysregulation, and renal impairment, thereby amplifying systemic inflammatory responses during SBP. Consequently, therapeutic strategies targeting oxidative stress may improve host defense while limiting organ injury.
N-acetylcysteine (NAC) is a precursor of glutathione and one of the most extensively studied antioxidant agents in clinical medicine. Besides restoring intracellular glutathione stores, NAC exerts anti-inflammatory, endothelial-protective, and immunomodulatory effects through inhibition of oxidative stress and pro-inflammatory cytokine production. On the other hand, experimental studies have further demonstrated that NAC can inhibit bacterial biofilm formation, enhance antibiotic penetration, and potentiate antimicrobial activity against several clinically important bacterial pathogens.
Despite these promising biological properties, the therapeutic role of NAC in active SBP has not been established. Previous data have primarily evaluated NAC for hepato- or renal protection in liver disease. While its potential role as an adjunctive antibacterial therapy during active SBP has not been investigated in adequately designed randomized controlled trials. Therefore, the present study will evaluate whether adjunctive NAC improves early treatment response and reduces subsequent organ dysfunction and short-term adverse outcomes.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
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
説明
Inclusion Criteria: Adult patients (≥18 years) with liver cirrhosis, confirmed by clinical, radiological, or histopathological findings, who are newly diagnosed with SBP based on an ascitic fluid polymorphonuclear (PMN) leukocyte count ≥250 cells/mm³ according to the American Association for the Study of Liver Diseases (AASLD) criteria (2). Eligible participants were required to have undergone diagnostic paracentesis for ascitic fluid analysis and to provide informed consent prior to enrollment.
Exclusion Criteria
- Secondary bacterial or fungal peritonitis.
- Recent abdominal surgery or requiring immediate surgical intervention.
- Known hypersensitivity to NAC.
- Pregnancy or lactation.
- Septic shock, established HRS-AKI requiring rescue therapy, or renal replacement therapy at enrollment.
- Advanced malignancy or terminal illness.
- Previous NAC administration during the current SBP episode.
- Inability to receive oral study medication.
- Participation in another interventional trial that may affect study outcomes.
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター:コントロール
|
Standard-of-care SBP therapy + matching placebo twice daily for 7 days.
|
|
アクティブコンパレータ:NAC
|
Standard-of-care SBP therapy + NAC 600 mg orally twice daily for 7 days.
|
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 |
|---|---|---|
|
Percentage change in ascitic-fluid polymorphonuclear (PMN) count from baseline to 48 hours after initiation of treatment
時間枠:48 H
|
Primary Outcome: Percentage change in ascitic-fluid polymorphonuclear (PMN) count from baseline to 48 hours after initiation of treatment. % change = [(48-h PMN - baseline PMN) / baseline PMN] × 100 |
48 H
|
協力者と研究者
スポンサー
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
本研究に関する用語
その他の研究ID番号
- N-Acetylcysteine
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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