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To Compare Inflammatory Marker levels and Magnetic Resonance Spectroscopy Characteristics in Liver Cirrhotics with Minimal And Grade 1 Hepatic Encephalopathy

Comparison of Inflammatory Markers, Magnetic Resonance Spectroscopy Characteristics And Natural History of Liver Cirrhotics with Minimal And Grade 1 Hepatic Encephalopathy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/059338
Enrollment
150
Registered
2023-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: NIL: NIL

Sponsors

Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with evidence of cirrhosis on ultrasound, fibroscan or liver histopathology if available

Exclusion criteria

Exclusion criteria: Contraindications of MR spectroscopy including cardiac pacemaker without MRI compatibility, implanted cardioverter defibrillator, cochlear implant, claustrophobia etc. Pregnancy Patients with hepatic encephalopathy of Grade 2 or higher (By West Haven criteria) in the past History of GI bleed in last one-month, spontaneous bacterial peritonitis (SBP) on prophylaxis or hepatorenal syndrome (HRS) and patients of acute on chronic liver failure (ACLF). Patients who have received Lactulose, Rifaximin, LOLA, probiotics or anti-inflammatory drugs such as steroids and NSAIDs. History of use of psychotropic drugs in last 6 weeks Poor vision precluding neuropsychological assessment. Patients with known neurological illness History of TIPSS or Shunt surgery Active ongoing infection Hepatocellular carcinoma or severe medical problems such as congestive heart failure, pulmonary disease, or neurological or psychiatric disorder.

Design outcomes

Primary

MeasureTime frame
Mean concentration peak levels of myoinositol, choline, creatinine and glutamate in MR spectroscopy in cirrhotics with minimal and grade 1 HE Mean serum levels of inflammatory markers like TNF-alpha, IL-6, IL-18 in pg/ml and endotoxin in EU/ml in cirrhotics with minimal and grade 1 HE Timepoint: At baseline—

Secondary

MeasureTime frame
Proportion of patients with development of complications such as worsening of hepatic encephalopathy, gastrointestinal bleed, infections or death.Timepoint: 1 monthly—

Countries

India

Contacts

Public ContactDr Bhatt Shrey Nandkishor

Govind Ballabh Pant Institute of Post Graduate Medical Education and Research, New Delhi

docsiddharth1@gmail.com9718599215

Outcome results

None listed

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