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Analysis of proteins to differentiate between infected and non-infected ACLF patients

Untargeted proteomics profiling in sepsis due to fungal and bacterial infections in patients with acute on chronic liver failure: a case-control study. - PACIFY

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/12/038725
Enrollment
100
Registered
2021-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K74- Fibrosis and cirrhosis of liver

Interventions

None listed

Sponsors

Post Graduate Institute of Medical Education and Research PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ACLF patients: i. Age 18-80 years ii. Giving a positive consent

Exclusion criteria

Exclusion criteria: Patients with i. Human immunodeficiency virus infection ii. Pregnancy, iii. Previous liver or other organ transplantation iv. Known immunosuppressed states (steroid use in previous 6 months) and v. Those refusing to give consent will be excluded.

Design outcomes

Primary

MeasureTime frame
To compare the clinical and plasma proteomic profile between ACLF patients with culture-proven infections (bacterial and/or fungal) and ACLF patients without infectionsTimepoint: Recruitment & follow up of patients and simultaneous proteomic analysis for first 16 months. Validation of results in next 3 months. Final data analysis 3 months.

Secondary

MeasureTime frame
To compare the clinical and plasma proteomic profile between ACLF patients with culture-proven bacterial infections and culture proven fungal infections.Timepoint: Recruitment & follow up of patients and simultaneous proteomic analysis for first 16 months. ;To compare the clinical and plasma proteomic profile between survivors and non-survivors amongst patients with ACLF.Timepoint: Recruitment & follow up of patients and simultaneous proteomic analysis for first 16 months. ;To compare clinical and proteomic profile between patients with culture-proven infections as a precipitant for ACLF and culture-proven infections as a complication during the course of ACLF.Timepoint: Recruitment & follow up of patients and simultaneous proteomic analysis for first 16 months. ;To compare the proteomic profile between patients with different grades of ACLF.Timepoint: Recruitment & follow up of patients and simultaneous proteomic analysis for first 16 months. ;To compare the proteomic profile between ACLF patients without infection and healthy controls.Timepoint: Recruitment & follow up of patients and simultaneous proteomic analysis for first 16 months. ;To validate the proteomic markers identified on primary analysis in the baseline samples of patients with ACLF.Timepoint: Validation of results from discovery phase during months 17-19. Final data analysis 3 months.

Countries

India

Contacts

Public ContactDr Nipun Verma

PGIMER, Chandigarh

nipun29j@gmail.com9914208562

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026