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Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients.

Sponsor
Institute of Liver and Biliary Sciences, India (Other)
Overall Status
Unknown status
CT.gov ID
NCT04474262
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
8.5
Anticipated Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Albumin
  • Drug: Midodrine Oral Tablet
  • Other: Placebo
 N/A

Detailed Description

OBJECTIVE:

Primary objective: Incidence of Paracentesis induced circulatory dysfunction in patients undergoing modest volume paracentesis (MVP) (>3 and <5 litres) with midodrine plus 25% albumin v/s 25% albumin infusion alone at day 7

Secondary objective:

  • Change in systolic, diastolic and mean BP at day 3 and 6

  • Increase in plasma renin activity at day 6

  • Incidence of Hyponatremia, HE and AKI at day 3 and 6

  • Predictors of Paracentesis induced circulatory dysfunction

  • Predictors of 28 day survival.

Methodology :

Patients with Acute on chronic liver failure having grade III ascites will be given either albumin or albumin plus midodrine. Midodrine will be started 4 hrs before tap to achieve target MAP. Ascitic tapping will be followed by vital monitoring and monitoring of vital parameters along with measurement of changes in s. rennin at day 3 and 6.

  • All patient will be undergo complete physical examination and complete clinical history will be recorded.

  • Baseline cbc,LFT,KFT and INR level will be sent on day 1 along with baseline s. renin levels

  • Those eligible will be randomised in to two groups

  • GROUP A will be given albumin 8g/l of ascitic tap during tap along with placebo for 7 days.

  • GROUP B will be given midodrine 7.5 mg to 12.5 mg tds (keeping the target MAP above 70 mmhg)for 7 days plus albumin same as in other group.

Study Population: Patients of acute on chronic liver failure who are admitted to and attending the OPD at ILBS.

Study Design: Randomized controlled trial Study Period:NOV 2019 to march 2019

Sample Size:

Considering incidence of PICD in albumin group is 30% and reduction to 10% by adding midodrine with alpha =5%, and power of study being 80%. No. of cases in each group- 66 Total-132 Furthur with 10% dropout we need to enroll 150 cases (75 in each group) randomly allocated in two groups by block randomization method with block size of 5.

  • Intervention: This RCT will be conducted at ILBS New Delhi between Dec 2019 and March 2021

  • Monitoring and assessment:

  • All patient will be undergo complete physical examination and complete clinical history will be recorded.

  • Baseline cbc,LFT,KFT and INR level will be sent on day 1 along with baseline s. renin levels

  • Those eligible will be randomised in to two groups

  • GROUP A will be given albumin 8g/l of ascitic tap along with placebo for 7 days. Standard albumin therapy will continue (40gm/week)

  • GROUP 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.

Expected outcome of the project:
Primary:
  • Incidence of PICD at day 3 and day6
Secondary:

  • Changes in hemodynamic parameters at 1, 3 and 6 hour, Day 3, Day 6 post paracentesis

  • Increase in plasma renin activity at Day 3, Day 6

  • Incidence of Hyponatremia, HE and AKI at day 3 and 6

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients-A Randomized Controlled Trial.
Anticipated Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Albumin with placebo

Group A will be given albumin 8g/l of ascitic tap along with placebo for 7 days. Standard albumin therapy will continue (40gm/week)

Biological: Albumin
Albumin will be 8g/l of ascitic tap. Standard albumin therapy will continue (40gm/week)

Other: Placebo
Placebo
Experimental: Albumin with Midodrine

GROUP 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.

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).

Outcome Measures

Primary Outcome Measures

  1. Incidence of PICD (Paracentesis Induced Circulatory Dysfunction) [Day 3]

  2. Incidence of PICD (Paracentesis Induced Circulatory Dysfunction) [Day 6]

Secondary Outcome Measures

  1. Changes in Mean Arterial Pressure (MAP) post paracentesis. [1 hour]

  2. Changes in Heart Rate post paracentesis. [1 hour]

  3. Changes in Mean Arterial Pressure (MAP) post paracentesis. [3 hours]

  4. Changes in Heart Rate post paracentesis. [3 hours]

  5. Changes in Mean Arterial Pressure (MAP) post paracentesis. [6 hours]

  6. Changes in Heart Rate post paracentesis. [6 hours]

  7. Changes in Mean Arterial Pressure (MAP) post paracentesis. [Day 3]

  8. Changes in Heart Rate post paracentesis. [Day 3]

  9. Changes in Mean Arterial Pressure (MAP) post paracentesis. [Day 6]

  10. Changes in Heart Rate post paracentesis. [Day 6]

  11. Change in plasma renin activity in both groups [Day 3]

  12. Change in plasma renin activity in both groups [Day 6]

  13. Incidence of Hyponatremia in both groups [Day 3]

  14. Incidence of Hyponatremia in both groups [Day 6]

  15. Incidence of Hepatic Encephalopathy in both groups [Day 3]

  16. Incidence of Hepatic Encephalopathy in both groups [Day 6]

  17. Incidence of Acute Kidney Injury in both groups [Day 3]

  18. Incidence of Acute Kidney Injury in both groups [Day 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ACLF patients (as per APASL definition) with grade II/III ascites
Exclusion Criteria:

  1. Age < 18 or >75 years

  2. Hepatocellular carcinoma

  3. Extrahepatic portal vein obstruction

  4. Non cirrhotic ascites

  5. Serum creatinine >1.5mg/dl

  6. Refractory septic shock

  7. Beta blockersPortal vein thrombosis

  8. Grade 3-4 HE

  9. Pregnancy or Lactation

  10. Active variceal bleed

  11. Respiratory, cardiac, renal failure

  12. Uncontrolled hypertension

  13. Severe coagulopathy

  14. Refusal to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Liver & Biliary Sciences New Delhi Delhi India 110070

Sponsors and Collaborators

  • Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT04474262
Other Study ID Numbers:
  • ILBS-ACLF-06
First Posted:
Jul 16, 2020
Last Update Posted:
Jul 16, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Midodrine

Study Results

No Results Posted as of Jul 16, 2020