COMPARISON OF MIDODRINE+STANDARD MEDICAL THERAPY AND STANDARD MEDICAL THERAPY ALONE IN CIRRHOSIS ASSOCIATED REFRACTORY ASCITES PATIENTS

AN OPEN-LABELLED BLINDED ENDPOINT RANDOMISED TRIAL (PROBE) TO ASSESS THE EFFICACY AND KINETICS OF MIDODRINE IN CIRRHOSIS ASSOCIATED REFRACTORY ASCITES PATIENTS - PROBE TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065206

Enrollment

Registered

2024-04-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Intervention1: MIDODRINE+STANDARD MEDICAL THERAPY : MIDODRINE 5mg orally three times daily and dose increased by 2.5mg every fourth day after checking BP, weight and creatinine, till achieving a mea

Eligibility

Inclusion criteria

Inclusion criteria: Definite history of cirrhosis with refractory ascites, ascites evidenced by USG and stable renal function.

Exclusion criteria

Exclusion criteria: Heart failure with ascites, serum creatinine greater than 1.5 mg/dl, anuria, gastrointestinal bleeding, HRS, grade 2 encephalopathy.

Design outcomes

Primary

Measure	Time frame
Control of ascites determined by change in weight, need of LVP, USG imaging.Timepoint: 28 days	—

Secondary

Measure	Time frame
Determine serum drug concentration of midodrine, responsiveness to midodrine by assessing mean arterial pressure, urine sodium and pottassium, renal function and liver function, assess change in serum sodium and pottasium and to assess treatment emergent ADRs.Timepoint: 28 days	—

Countries

India

Contacts

Public ContactDr ARUN VALSAN

Amrita Institute of Medical Sciences and Research Center, Kochi

drarunvalsan@gmail.com8411051156

Outcome results

None listed

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