"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University

About this trial

This study aims to evaluate beneficial effects of using dapagliflozin in cirrhotic chronic liver disease patients. We hypnotized that the use of dapagliflozin will be associated with fewer need for large volume paracentesis hence better control of ascites, fewer need for ICU admissions, improvement of patient quality of life, better healthcare cost saving and reduced mortality rate.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study.

Disqualifiers

Child Pugh score ≥ 12 or MELD score > 25.

Previous history of hypoglycemia or has a previous history of DKA.

Blood pressure less than 90/60 or need dose of midodrine >15 mg/day.

Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin

    Drug

    Dapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Group ANo intervention 0 interventions
Group B: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of times patient need Paracentesis to control Ascites

Decrease need for large volume paracentesis in the intervention group than in the control group which indicate better control of Ascites within 3 months from the start of intervention.

Time frame
3 months

Secondary outcomes

1

incidence of Cirrhosis sequelae

• Reduced incidence of Cirrhosis sequelae (hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, variceal bleeding) in the intervention group as compared to control group.

Time frame
3 months

Other outcomes

1

quality of life using SF-36 questionnaire

• Improvement of patient quality of life in the intervention group as compared to control group.

Time frame
3 months

Sponsors and contacts

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