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临床试验/CTRI/2026/03/105291
CTRI/2026/03/105291尚未招募不适用

Comparison of mortality in carbapenem resistant gram negative infections in sepsis patients with or without liver cirrhosis: A prospective observational study

Dr Aditya Parashar1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年3月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1

研究概览

简要总结

Carbapenem-resistant gram-negative bacteria (CRGN) are increasingly recognized as critical pathogens causing severe infections, especially in critically ill patients with sepsis. These multidrug-resistant organisms, including species like Enterobacteriacea, Pseudomonas aeruginosa, and Acinetobacter baumannii, pose significant clinical challenges due to limited therapeutic options and high mortality rates. Sepsis caused by CRGN often leads to prolonged hospitalization, increased healthcare costs, and poor patient outcomes, making early identification and appropriate management vital.

Patients with liver cirrhosis represent a particularly vulnerable population for CRGN infections. Cirrhosis induces systemic immunodeficiency and disrupts the gut-liver axis, promoting bacterial translocation and colonization by multidrug-resistant organisms. This immunocompromised state, coupled with frequent healthcare exposures such as hospital admissions, antibiotic treatments, and invasive procedures, substantially increases infection risk. Bacterial infections in cirrhotic patients frequently precipitate acute decompensation and acute-on-chronic liver failure, conditions associated with high morbidity and mortality. Emerging data indicate that the presence of CRGN infections in cirrhotic patients further worsens outcomes compared to non-cirrhotic individuals, emphasizing the need for focused clinical attention.

Despite the recognized threat, comparative data investigating the clinical features, molecular resistance mechanisms, and patient outcomes of CRGN infections in sepsis with and without cirrhosis remain limited. Understanding differences in mortality, organ dysfunction, and risk factors between these groups is essential to optimize diagnostic and therapeutic strategies. Additionally, characterization of carbapenemase enzymes (e.g., KPC, NDM, VIM, OXA-48, IMP) responsible for resistance can guide effective antimicrobial therapy.

This study aims to prospectively assess 30-day mortality in CRGN infections in sepsis patients with and without liver cirrhosis and to evaluate secondary outcomes including risk factors for infection, resistance patterns, organ dysfunction, ICU/hospital stay duration, and antibiotic susceptibility profiles, ultimately aiming to improve patient management and reduce mortality associated with these challenging infections.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age: Adult patients (18 years).
  • Diagnosis: Sepsis, defined according to Sepsis-3 criteria.
  • Microbiological confirmation: Presence of carbapenem-resistant Gram-negative (CRGN) infections.
  • Source of isolates: Confirmed from blood cultures or samples obtained from other sterile sites, including: Ascitic fluid Cerebrospinal fluid Urine Respiratory secretions.

排除标准

  • Patients with solid organ transplants other than liver within six months 2) Patients with primary immunodeficiency disorders 3) Patients with HIV infection 4) Patients with who decline consent 5) Patients with CRGN colonization without active infection.

研究者

发起方
Dr Aditya Parashar
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Aditya Parashar

Amrita School of Medicine

研究点 (1)

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