Cirrhosis
Conditions
Keywords
cirrhosis, spontaneous bacterial peritonitis, ciprofloxacin
Brief summary
Spontaneous bacterial peritonitis (SBP) is one of the leading causes of morbidity and mortality in patients with cirrhosis. Spontaneous bacterial peritonitis (SBP) is a common bacterial infection in patients with cirrhosis and ascites, occurring in 10 to 30% of patients, with in-hospital mortality rates ranging from 20 to 30%1. Early diagnosis and a prompt antibiotic therapy have considerably decreased the mortality rate associated with an episode of SBP from 80% to approximately 20- 30% in the last decade. It is secondary to impaired humoral and cellular immune responses that results in indirect intestinal bacterial translocation into the ascitic fluid 2,3. The incidence of spontaneous bacterial peritonitis in hospitalised patients with cirrhosis varies from 7-23% in the West. It is around 33% in Pakistan. Translocation of bacteria (mostly gram negative) from the intestinal lumen due to decreased phagocytic activity of macrophages and increased intestinal permeability in cirrhotic patients is an important step in the development of spontaneous bacterial peritonitis. Spontaneous bacterial peritonitis is also associated with a poor long-term prognosis for patients, as mortality rates can reach 50 to 70% at 1 year
Detailed description
Recent attention drawn to the changing microbial and resistance patterns attributed to the increasing use of antibiotic prophylaxis and invasive procedures in such patients further underscores the importance of identifying the causative pathogen to ensure adequate antibiotic coverage 5,6. Symptomatic spontaneous bacterial peritonitis can be present as first presentation of ascites in chronic liver Page \| 4disease patients7. Patients with spontaneous bacterial peritonitis has a mortality rate ranging between 30-50%8 early diagnosis and prompt treatment with antibiotic can save patients lives9. Different options in antibiotics are ceftriaxone, cefotaxime, ampicillin, ciprofloxacin, ofloxacin and metronidazole. Cefotaxime or ceftriaxone were considered the first-choice antibiotic for empirical treatment in cirrhotic patients developing spontaneous bacterial peritonitis. It has been suggested that ciprofloxacin could be an alternative to cefotaxime or ceftriaxone in cirrhotic patients developing spontaneous bacterial peritonitis 7
Interventions
DRUGintravenous ciprofloxacin
In group A, 155 patients will be given intravenous ciprofloxacin 200mg 12 hourly. Treatment will be given for consecutive 48 hours. Ascitic fluid tap will be done before and then 48 hours after the antibiotic initiation by the researcher himself and sent to the hospital laboratory. Total duration of treatment will be of 5 days9and efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, resolution of abdominal pain, determining the ascitic fluid neutrophil count after 48 hours
DRUGintravenous ceftriaxone
in group B 155 patients on ceftriaxone 1g 12 hourly. Treatment will be given for consecutive 48 hours. Ascitic fluid tap will be done before and then 48 hours after the antibiotic initiation by the researcher himself and sent to the hospital laboratory. Total duration of treatment will be of 5 days9and efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, resolution of abdominal pain, determining the ascitic fluid neutrophil count after 48 hours
Sponsors
Shahida Islam Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed with spontaneous bacterial peritonitis: Child Pugh class A, B and C, confirmed from record file of the patient. Male and female patients from the age of 25-70 years with liver cirrhosis
Exclusion criteria
* Hemorrhagic or malignant ascites. (on history). * Tuberculous with secondary peritonitis (on medical record file). * Hepatocellular carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of efficacy | 1 month | efficacy of treatment will be determined by means of evaluating clinical symptoms, i.e., decrease in temperature to normal 98.6°F, absence of abdominal pain, reduction of the ascitic fluid neutrophil count to \<250 cells /mm³ after 48 hours of antibiotic therapy. Fever : Oral temperature \>38° C measured using a digital thermometer |
Countries
Pakistan
Outcome results
None listed