Clinical trial NCT05117073: Risk Factors of Spontaneous Fungal Peritonitis in Cirrhotic Patients
Official title: Risk Factors of Spontaneous Fungal Peritonitis in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontanous Fungal Peritonitis
Keywords: spontanous fungal peritonitis, liver cirrhosis, risk factors
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals

Brief summary: Spontaneous bacterial peritonitis (SBP) is an infection of the peritoneal cavity with no surgically treatable intra-abdominal source of infection. Spontaneous peritonitis is a potentially fatal complication in patients with advanced liver cirrhosis. It is estimated that 10-20 % of patients with cirrhotic ascites may develop spontaneous peritonitis, which is usually caused by a bacterial infection.

In contrast, spontaneous fungal peritonitis (SFP) is less well-recognized. SFP may be associated with higher mortality rates than SBP but therapeutic approaches are largely undefined. To this end, the epidemiology and outcomes of patients with SFP have only been documented sporadically aimed to evaluate the risk factors for the development of spontaneous fungal peritonitis (SFP), and the prognosis of SFP compared with SBP

Detailed description: Cross-sectional study

Studied population \& locality:

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals during the period from september 2021 to december 2022 will be included in the study.

According to the results of ascitic fluid analysis, we will divide the patients into 2 groups:

Group (1): patients with spontaneous bacterial peritonitis (SBP). Group (2): patients with spontaneous fungal peritonitis (SFP).

Exclusion criteria:

Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.

Methods:

All included patients will be subjected to:

1. Detailed history, complete general and systemic examination.
2. Ascitic fluid analysis
3. Bacterial and fungal culture from ascitic fluid:
4. Laboratory investigations:

Fasting blood sugar Liver function tests. CBC.

Ethical considerations:

Eligibility criteria: Inclusion Criteria:

Patients with signs and symptoms suggestive of spontaneous peritonitis who will be admitted to Tropical medicine and Gastroenterology or Internal medicine departments in Sohag university hospitals during the period from September 2021 to december 2022

Exclusion Criteria:

Patients seropositive for human immunodeficiency virus (HIV) and patients undergoing continuous ambulatory peritoneal dialysis were excluded from this study.

Primary outcomes:
measure: he risk factors for the development of spontaneous fungal peritonitis
timeFrame: September 2021 to December 2022 will be included in the study.
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mona Mohammed Abdelrahman
Study officials:
affiliation: Sohag University
name: Radwa Farag, MD
role: STUDY_CHAIR
affiliation: Sohag University
name: osamaa orabi, MD
role: STUDY_CHAIR
References:
citation: Hwang SY, Yu SJ, Lee JH, Kim JS, Yoon JW, Kim YJ, Yoon JH, Kim EC, Lee HS. Spontaneous fungal peritonitis: a severe complication in patients with advanced liver cirrhosis. Eur J Clin Microbiol Infect Dis. 2014 Feb;33(2):259-64. doi: 10.1007/s10096-013-1953-2. Epub 2013 Sep 2.
citation: Bremmer DN, Garavaglia JM, Shields RK. Spontaneous fungal peritonitis: a devastating complication of cirrhosis. Mycoses. 2015 Jul;58(7):387-93. doi: 10.1111/myc.12321. Epub 2015 Apr 7.
citation: Shizuma T. Spontaneous bacterial and fungal peritonitis in patients with liver cirrhosis: A literature review. World J Hepatol. 2018 Feb 27;10(2):254-266. doi: 10.4254/wjh.v10.i2.254.