Paracentesis-Induced Circulatory DysfunctionPhase 3NCT05240391
Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance
A Phase 3 study testing Midodrine Hydrochloride and Human Albumin 20% in people with Paracentesis-Induced Circulatory Dysfunction, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in decompensated cirrhosis during large-volume paracentesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paracentesis-Induced Circulatory Dysfunction
- What is being tested?
- Midodrine Hydrochloride and Human Albumin 20%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 20 Feb 2021to 5 May 2022
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients above 18 years of age who fulfilled Asia Pacific Association of study of liver disease (APASL) criteria for ACLF and required paracentesis for moderate to tense ascites were included in the study.
- Acute on Chronic Liver Failure (ACLF) was defined as an acute hepatic insult manifesting as jaundice (Serum bilirubin ≥ 5 mg/dL (85 micromole/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis and is associated with a high 28-day mortality -
Who cannot join
- Patients with acute kidney injury defined as serum creatine of > 0.3 mg/dl above the baseline
- Severe cardiopulmonary disease
- History of urinary retention
- Pheochromocytoma
- Thyrotoxicosis
- Persistent and excessive supine hypertension define by systolic blood pressure > 150 mm Hg
- Pregnant patients
- Unable to give informed consent were excluded from the study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midodrine Versus Albumin During Large-volume Paracentesis and Its Effect on Paracentesis Induced Circulatory Disturbance in Patients With Acute on Chronic Liver Failure - A Randomized Controlled Trial
Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in decompensated cirrhosis during large-volume paracentesis. However, it may not be cost-effective and has side effects like volume overload and transfusion reactions.
Therefore the investigator proposed to use midodrine which is a drug that increases the mean arterial pressure. The investigators hypothesized that midodrine may be effective in preventing PICD in acute on chronic liver failure patients requiring modest paracentesis. This has already been found to be effective in initial studies in decompensated cirrhosis
- Being tested
- Midodrine Hydrochloride, Human Albumin 20%
- Keywords
- Ascites, Paracentesis-Induced Circulatory Dysfunction, Paracentesis
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine HydrochlorideDrug
Midodrine hydrochloride for PICD prevention
Human Albumin 20%Drug
Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance
| Study group | Role | What they receive |
|---|---|---|
| Arm receiving 20% Human Albumin | Active comparator | 20% Human albumin given intravenously over 4 hours Receives: Drug: Human Albumin 20% |
| Arm receiving Midodrine | Experimental | Tablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis Receives: Drug: Midodrine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of Paracentesis induced circulatory disturbance
Measure the value of plasma renin activity on sixth day after paracentesis
Measured: Day 6
Secondary outcomes (3)
Cost effectiveness of Midodrine versus Albumin
Cost effectiveness of use of Midodrine compared to Albumin
Measured: Day 6
Hepatic Encephalopathy as measured by West-Haven criteria
Hepatic encephalopathy as measured by the West Haven criteria on day 6 in both midodrine and albumin groups
Measured: Day 6
Renal outcome post paracentesis
Serum creatinine, serum sodium and serum potassium values on day 6 after paracentesis
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 posted15 Feb 2022
- Study start20 Feb 2021
- Primary completion1 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Paracentesis-Induced Circulatory DysfunctionStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mithun Sharma, Asian Institute of Gastroenterology, India
- Investigators
- MITHUN SHARMA, MD FACG AGAF, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240391
- Sponsor's protocol ID
- AIGHEPAT007
- Status last verified
- May 2022
- First submitted
- 3 Jan 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shrestha DB, Budhathoki P, Sedhai YR, Baniya R, Awal S, Yadav J, Awal L, Davis B, Kashiouris MG, Cable CA. Safety and efficacy of human serum albumin treatment in patients with cirrhotic ascites undergoing paracentesis: A systematic review and meta-analysis. Ann Hepatol. 2021 Dec;26:100547. doi: 10.1016/j.aohep.2021.100547. Epub 2021 Oct 6.
PubMed 34626828Kulkarni AV, Kumar P, Sharma M, Sowmya TR, Talukdar R, Rao PN, Reddy DN. Pathophysiology and Prevention of Paracentesis-induced Circulatory Dysfunction: A Concise Review. J Clin Transl Hepatol. 2020 Mar 28;8(1):42-48. doi: 10.14218/JCTH.2019.00048. Epub 2020 Mar 26.
PubMed 32274344Bai M, Han G. Midodrine for paracentesis-induced circulatory dysfunction. J Clin Gastroenterol. 2014 Mar;48(3):300. doi: 10.1097/MCG.0b013e3182a8bfaf. No abstract available.
PubMed 24100756
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine Versus Albumin During Large-volume Paracentesis and Its Effect on Paracentesis Induced Circulatory Disturbance in Patients With Acute on Chronic Liver Failure - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05240391
- Acronym / sponsor ID
- AIGHEPAT007
- Keywords
- Ascites, Paracentesis-Induced Circulatory Dysfunction, Paracentesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 15 Feb 2022 (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.
Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in decompensated cirrhosis during large-volume paracentesis. However, it may not be cost-effective and has side effects like volume overload and transfusion reactions.
Therefore the investigator proposed to use midodrine which is a drug that increases the mean arterial pressure. The investigators hypothesized that midodrine may be effective in preventing PICD in acute on chronic liver failure patients requiring modest paracentesis. This has already been found to be effective in initial studies in decompensated cirrhosis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm receiving 20% Human Albumin | Active comparator | Drug: Human Albumin 20%20% Human albumin given intravenously over 4 hours |
| Arm receiving Midodrine | Experimental | Drug: Midodrine HydrochlorideTablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive patients above 18 years of age who fulfilled Asia Pacific Association of study of liver disease (APASL) criteria for ACLF and required paracentesis for moderate to tense ascites were included in the study.
- Acute on Chronic Liver Failure (ACLF) was defined as an acute hepatic insult manifesting as jaundice (Serum bilirubin ≥ 5 mg/dL (85 micromole/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis and is associated with a high 28-day mortality -
Key exclusion criteria (8 listed)
- Patients with acute kidney injury defined as serum creatine of > 0.3 mg/dl above the baseline
- Severe cardiopulmonary disease
- History of urinary retention
- Pheochromocytoma
- Thyrotoxicosis
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 |
|---|---|---|
| Midodrine HydrochlorideMidodrine hydrochloride for PICD prevention | Drug | Arm receiving Midodrine |
| Human Albumin 20%Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance | Drug | Arm receiving 20% Human Albumin |
Primary outcome
Prevention of Paracentesis induced circulatory disturbance
Time frame: Day 6
Measure the value of plasma renin activity on sixth day after paracentesis
3 secondary outcomes
Cost effectiveness of Midodrine versus Albumin
Time frame: Day 6
Hepatic Encephalopathy as measured by West-Haven criteria
Time frame: Day 6
Renal outcome post paracentesis
Time frame: Day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Results publication: PubMed 34626828Shrestha DB, Budhathoki P, Sedhai YR, Baniya R, Awal S, Yadav J, Awal L, Davis B, Kashiouris MG, Cable CA. Safety and efficacy of human serum albumin treatment in patients with cirrhotic ascites undergoing paracentesis: A systematic review and meta-analysis. Ann Hepatol. 2021 Dec;26:100547. doi: 10.1016/j.aohep.2021.100547. Epub 2021 Oct 6.
- Results publication: PubMed 32274344Kulkarni AV, Kumar P, Sharma M, Sowmya TR, Talukdar R, Rao PN, Reddy DN. Pathophysiology and Prevention of Paracentesis-induced Circulatory Dysfunction: A Concise Review. J Clin Transl Hepatol. 2020 Mar 28;8(1):42-48. doi: 10.14218/JCTH.2019.00048. Epub 2020 Mar 26.
- Results publication: PubMed 24100756Bai M, Han G. Midodrine for paracentesis-induced circulatory dysfunction. J Clin Gastroenterol. 2014 Mar;48(3):300. doi: 10.1097/MCG.0b013e3182a8bfaf. No abstract available.
- Individual participant dataSharing planned: No
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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.
MITHUN SHARMA, MD FACG AGAF principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midodrine Hydrochloride and Human Albumin 20% in people with Paracentesis-Induced Circulatory Dysfunction, run by Asian Institute of Gastroenterology, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 10 May 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Paracentesis induced circulatory disturbance (time frame: Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05240391, which also lists 3 linked publications.
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 10 May 2022.