Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients.
1 other identifier
interventional
150
1 country
1
Brief Summary
The patients with ACLF having Ascites who require ascitic tapping will undergone ascitic tapeither under albumin cover alone or with midodrine. The patient will be monitored for complication and changes of PICD. Study analysis will be done with primary objective being reduction in incidence of PICD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2020
CompletedStudy Start
First participant enrolled
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedJuly 16, 2020
June 1, 2020
9 months
July 1, 2020
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
Day 3
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
Day 6
Secondary Outcomes (18)
Changes in Mean Arterial Pressure (MAP) post paracentesis.
1 hour
Changes in Heart Rate post paracentesis.
1 hour
Changes in Mean Arterial Pressure (MAP) post paracentesis.
3 hours
Changes in Heart Rate post paracentesis.
3 hours
Changes in Mean Arterial Pressure (MAP) post paracentesis.
6 hours
- +13 more secondary outcomes
Study Arms (2)
Albumin with placebo
ACTIVE COMPARATORGroup A will be given albumin 8g/l of ascitic tap along with placebo for 7 days. Standard albumin therapy will continue (40gm/week)
Albumin with Midodrine
EXPERIMENTALGROUP B will be given midodrine 7.5 mg to 10 mg tds (keeping the target MAP above 70 mmhg)for 7 days plus albumin same as in other group.
Interventions
Albumin will be 8g/l of ascitic tap. Standard albumin therapy will continue (40gm/week)
Midodrine 7.5 mg to 10 mg TDS (keeping the target MAP above 70 mmHg).
Eligibility Criteria
You may qualify if:
- \- ACLF patients (as per APASL definition) with grade II/III ascites
You may not qualify if:
- Age \< 18 or \>75 years
- Hepatocellular carcinoma
- Extrahepatic portal vein obstruction
- Non cirrhotic ascites
- Serum creatinine \>1.5mg/dl
- Refractory septic shock
- Beta blockersPortal vein thrombosis
- Grade 3-4 HE
- Pregnancy or Lactation
- Active variceal bleed
- Respiratory, cardiac, renal failure
- Uncontrolled hypertension
- Severe coagulopathy
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2020
First Posted
July 16, 2020
Study Start
July 15, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
July 16, 2020
Record last verified: 2020-06