The NACSELD database comprises prospectively collected data following informed consent from patients with cirrhosis hospitalized in 18 hepatology referral centers across the USA and Canada. Patients with an infection or who subsequently develop nosocomial infections are included. The study has been approved by the respective Institutional Review Boards of the participating centers and uses a REDCap (Research Electronic Data Capture) tool that is located at Virginia Commonwealth University. REDCap is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources.
Cirrhosis is diagnosed with a combination of biochemical, radiological and endoscopic findings if liver biopsy confirmation is not available. Patients who had infections but did not require hospital admission were excluded, as were patients who did not have an infection during their admission. Other exclusion criteria include immuno-compromised patients with human immunodeficiency virus (HIV) infection, prior organ transplant, and disseminated malignancies.
Once informed consent is obtained, data collection begins with patient demographic, vital signs, baseline full blood count, biochemistry, and assessment of liver and renal function. Details of the infection include antibiotic treatment as well as documentation of a second infection when applicable. Data regarding intensive care unit admissions, organ failures, liver transplantation, and length of hospital stay are also collected. Patients who are discharged alive are contacted at 30 days post-enrolment to determine survival.
We define infections according to standard criteria(4 (link)): (a) spontaneous bacteremia: positive blood cultures without a source of infection; (b)SBP : ascitic fluid polymorphonuclear cells >250/μL; (c) lower respiratory tract infections: new pulmonary infiltrate in the presence of: (i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with (ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature >38°C or less than 36 °C, shivering or leucocyte count >10,000/mm3 or <4,000/mm3) in the absence of antibiotics; (d) Clostridium difficile Infection: diarrhea with a positive C. difficile assay; (e) bacterial entero-colitis: diarrhea or dysentery with a positive stool culture for Salmonella, Shigella, Yersinia, Campylobacter, or pathogenic E. coli; (f) soft-tissue/skin Infection: fever with cellulitis; (g) urinary tract infection (UTI): urine white blood cell >15/high power field with either positive urine gram stain or culture; (h) intra-abdominal infections: diverticulitis, appendicitis, cholangitis etc; (i) other infections not covered above, and (j) fungal infections as a separate category. Nosocomial infections were those diagnosed after 48 hours of admission while second infections were those that were diagnosed after a separate first infection had been documented.
We used standard organ failure definitions as (i) hepatic encephalopathy >grade III or IV by West Haven Criteria (ii) shock: [mean arterial pressure (MAP) < 60 mm Hg or a reduction of 40 mmHg in systolic blood pressure from baseline] despite adequate fluid resuscitation and cardiac output, (iii) need for mechanical ventilation and (iv) need for dialysis or other forms of renal replacement therapy. These simple definitions are used to ensure generalizability.
Cirrhosis is diagnosed with a combination of biochemical, radiological and endoscopic findings if liver biopsy confirmation is not available. Patients who had infections but did not require hospital admission were excluded, as were patients who did not have an infection during their admission. Other exclusion criteria include immuno-compromised patients with human immunodeficiency virus (HIV) infection, prior organ transplant, and disseminated malignancies.
Once informed consent is obtained, data collection begins with patient demographic, vital signs, baseline full blood count, biochemistry, and assessment of liver and renal function. Details of the infection include antibiotic treatment as well as documentation of a second infection when applicable. Data regarding intensive care unit admissions, organ failures, liver transplantation, and length of hospital stay are also collected. Patients who are discharged alive are contacted at 30 days post-enrolment to determine survival.
We define infections according to standard criteria(4 (link)): (a) spontaneous bacteremia: positive blood cultures without a source of infection; (b)
We used standard organ failure definitions as (i) hepatic encephalopathy >grade III or IV by West Haven Criteria (ii) shock: [mean arterial pressure (MAP) < 60 mm Hg or a reduction of 40 mmHg in systolic blood pressure from baseline] despite adequate fluid resuscitation and cardiac output, (iii) need for mechanical ventilation and (iv) need for dialysis or other forms of renal replacement therapy. These simple definitions are used to ensure generalizability.