Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients.
NCT04474262 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2020-07-16
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.
Conditions
- Acute-On-Chronic Liver Failure
Interventions
- BIOLOGICAL
-
Albumin
Albumin will be 8g/l of ascitic tap. Standard albumin therapy will continue (40gm/week)
- DRUG
-
Midodrine Oral Tablet
Midodrine 7.5 mg to 10 mg TDS (keeping the target MAP above 70 mmHg).
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
-
Institute of Liver and Biliary Sciences, India
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-15
- Primary Completion
- 2021-03-31
- Completion
- 2021-03-31
Countries
- India
Study Locations
More Related Trials
-
Acute Hemodynamics of Albumin Versus Normal Saline in Cirrhosis
NCT00511394 ·Status: SUSPENDED ·Phase: NA
-
Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.
NCT06245590 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Targeted And Response-Guided Albumin Therapy Versus Standard Medical Treatment In Outcomes Of Recurrent Ascites In Patients With Decompensated Cirrhosis.
NCT04679571 ·Status: UNKNOWN ·Phase: NA
-
Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites
NCT06091345 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis
NCT03144713 ·Status: COMPLETED ·Phase: NA
-
Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites
NCT02173288 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis
NCT01288794 ·Status: COMPLETED ·Phase: PHASE4
-
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
NCT00108355 ·Status: COMPLETED ·Phase: PHASE4
-
High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
NCT02718079 ·Status: COMPLETED ·Phase: NA
-
Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis
NCT05956197 ·Status: UNKNOWN
-
Effect of Midodrine and Albumine in the Prevention of Complications in Cirrhotic Patients Awaiting Liver Transplantation
NCT00839358 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
NCT00968695 ·Status: COMPLETED ·Phase: PHASE4
-
Coagulation Parameters With Albumin in Decompensated Cirrhosis (CoPA-D).
NCT05937048 ·Status: COMPLETED ·Phase: NA
-
Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites
NCT05056220 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluation of 'Melody' Paracentesis Device for Ascites Therapy
NCT03191851 ·Status: COMPLETED ·Phase: NA
-
Fresh Frozen Plasma as a Substitute for Albumin in Patients Receiving a Large Volume Paracentesis
NCT04109144 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites
NCT04406298 ·Status: UNKNOWN ·Phase: NA
-
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
NCT03451292 ·Status: COMPLETED ·Phase: PHASE3
-
High Dose Albumin in Refractory Ascites
NCT05867602 ·Status: RECRUITING ·Phase: PHASE2
-
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"
NCT01201720 ·Status: COMPLETED ·Phase: NA
-
Alfapump System Versus Transjugular Intrahepatic Portosystemic Shunt and Paracentesis in the Treatment of Ascites
NCT02612519 ·Status: TERMINATED ·Phase: NA
-
Phase Ib of Recombinant Human Albumin Injection
NCT04701697 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Crystalloid and Colloid I.V Fluid Therapy in Prevention of Paracentesis Induced Circulatory Dysfunction (PICD) and Renal Dysfunction in Patients With Decompensated Liver Cirrhosis in Egypt: a Randomized Piolet Study
NCT05220891 ·Status: UNKNOWN
-
Albumin Assisted Diuresis in Patients with Cirrhosis and Ascites
NCT06812390 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
NCT02583698 ·Status: COMPLETED ·Phase: NA