Acute-On-Chronic Liver FailureNCT04474262
Efficacy of Albumin Plus Midodrine v/s Albumin Alone in Reducing Incidence of Paracentesis Induced Circulatory Dysfunctions in ACLF Patients.
A study testing Albumin and Midodrine Oral Tablet in people with Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- Albumin and Midodrine Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jul 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACLF patients (as per APASL definition) with grade II/III ascites
Who cannot join
- Age < 18 or >75 years
- Hepatocellular carcinoma
- Extrahepatic portal vein obstruction
- Non cirrhotic ascites
- Serum creatinine >1.5mg/dl
- Refractory septic shock
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ajay Mishra, MD, 01146300000, ajaymishrapandit@gmail.com
About this study
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.
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.
Read the 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
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- Albumin, Midodrine Oral Tablet, Placebo
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminBiological
Albumin will be 8g/l of ascitic tap. Standard albumin therapy will continue (40gm/week)
Midodrine Oral TabletDrug
Midodrine 7.5 mg to 10 mg TDS (keeping the target MAP above 70 mmHg).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Albumin with placebo | Active comparator | Group A will be given albumin 8g/l of ascitic tap along with placebo for 7 days. Standard albumin therapy will continue (40gm/week) Receives: Biological: Albumin; Other: Placebo |
| Albumin with Midodrine | Experimental | 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. Receives: Biological: Albumin; Drug: Midodrine Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
Measured: Day 3
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
Measured: Day 6
Secondary outcomes (18)
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Measured: 1 hour
Changes in Heart Rate post paracentesis.
Measured: 1 hour
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Measured: 3 hours
Changes in Heart Rate post paracentesis.
Measured: 3 hours
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Measured: 6 hours
Changes in Heart Rate post paracentesis.
Measured: 6 hours
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Measured: Day 3
Changes in Heart Rate post paracentesis.
Measured: Day 3
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Measured: Day 6
Changes in Heart Rate post paracentesis.
Measured: Day 6
Change in plasma renin activity in both groups
Measured: Day 3
Change in plasma renin activity in both groups
Measured: Day 6
Incidence of Hyponatremia in both groups
Measured: Day 3
Incidence of Hyponatremia in both groups
Measured: Day 6
Incidence of Hepatic Encephalopathy in both groups
Measured: Day 3
Incidence of Hepatic Encephalopathy in both groups
Measured: Day 6
Incidence of Acute Kidney Injury in both groups
Measured: Day 3
Incidence of Acute Kidney Injury in both groups
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start15 Jul 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474262
- Sponsor's protocol ID
- ILBS-ACLF-06
- Status last verified
- Jun 2020
- First submitted
- 1 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04474262
- Acronym / sponsor ID
- ILBS-ACLF-06
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin with placebo | Active comparator | Biological: Albumin, Other: PlaceboGroup 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 | Experimental | Biological: Albumin, Drug: Midodrine Oral TabletGROUP 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACLF patients (as per APASL definition) with grade II/III ascites
Key exclusion criteria (14 listed)
- Age < 18 or >75 years
- Hepatocellular carcinoma
- Extrahepatic portal vein obstruction
- Non cirrhotic ascites
- Serum creatinine >1.5mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuminAlbumin will be 8g/l of ascitic tap. Standard albumin therapy will continue (40gm/week) | Biological | Albumin with Midodrine, Albumin with placebo |
| Midodrine Oral TabletMidodrine 7.5 mg to 10 mg TDS (keeping the target MAP above 70 mmHg). | Drug | Albumin with Midodrine |
| PlaceboPlacebo | Other | Albumin with placebo |
Primary outcome
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
Time frame: Day 3
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction)
Time frame: Day 6
18 secondary outcomes
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Time frame: 1 hour
Changes in Heart Rate post paracentesis.
Time frame: 1 hour
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Time frame: 3 hours
Changes in Heart Rate post paracentesis.
Time frame: 3 hours
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Time frame: 6 hours
Changes in Heart Rate post paracentesis.
Time frame: 6 hours
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Time frame: Day 3
Changes in Heart Rate post paracentesis.
Time frame: Day 3
Changes in Mean Arterial Pressure (MAP) post paracentesis.
Time frame: Day 6
Changes in Heart Rate post paracentesis.
Time frame: Day 6
Change in plasma renin activity in both groups
Time frame: Day 3
Change in plasma renin activity in both groups
Time frame: Day 6
Incidence of Hyponatremia in both groups
Time frame: Day 3
Incidence of Hyponatremia in both groups
Time frame: Day 6
Incidence of Hepatic Encephalopathy in both groups
Time frame: Day 3
Incidence of Hepatic Encephalopathy in both groups
Time frame: Day 6
Incidence of Acute Kidney Injury in both groups
Time frame: Day 3
Incidence of Acute Kidney Injury in both groups
Time frame: Day 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin and Midodrine Oral Tablet in people with Acute-On-Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ajay Mishra, MD (01146300000, ajaymishrapandit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PICD (Paracentesis Induced Circulatory Dysfunction) (time frame: Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.