Liver CirrhosisNCT06091345
Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites
A study testing Midodrine, albumin and Standard Medical Treatment in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Children with decompensated cirrhosis are more prone to develop various complications. The pathogenesis of cirrhotic complications (ascites, hyponatremia, acute kidney injury) includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Midodrine, albumin and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIndia
- Study dates
- 22 Dec 2023to 31 Dec 2025
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (≤ 18 years)
- Cirrhosis based on histological/ radiological + endoscopic evidence
- Clinical ascites (≥ grade 2 ascites)
- Informed consent from parents (Assent > 12 years)
Who cannot join
- Arterial hypertension (Mean Arterial Pressure ≥ 95th centile for age)
- Presence of Portal vein thrombosis
- Hepatorenal Syndrome
- Congestive Heart failure
- Respiratory failure(PF ratio <200)
- Septic shock
- Presence of Hepatocellular Carcinoma
- Transjugular intrahepatic Porto Systemic Shunt
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110 070
About this study
Official title: Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites - An Open Label Randomized Controlled Trial.
Children with decompensated cirrhosis are more prone to develop various complications. The pathogenesis of cirrhotic complications (ascites, hyponatremia, acute kidney injury) includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis (RAAS) causing sodium and water retention and renal vasoconstriction.
The development of complications in these children may result in death or may preclude them from reaching upto liver transplantation.
Read more
Midodrine is an α1 adrenergic receptor agonist, which increases vascular tone causing rise in the blood pressure, thereby improving renal perfusion and causes RAAS deactivation. The effects of midodrine is documented in reduction of refractory ascites, hepatorenal syndrome and hyponatremia.
Albumin is a protien that works by both increasing the colloidal oncotic pressure and improving systemic circulation as well as by effecting the body with anti-inflammatory and antioxidant properties.
We have already demonstrated the safety and efficacy of midodrine as well as albumin in cirrhotic children. However, none of these drugs alone provided survival benefit to the patients. Hence, we have planned this study with the ojective to evaluate if combining these 2 drugs (midodrine and albumin) would further reduce the complications and improve the survival in decompensated cirrhotic children.
Read the detailed description
Aim: To evaluate whether a combination of midodrine and intravenous albumin reduces complications of cirrhosis in decompensated (ascites) cirrhotic children as compared to midodrine alone.
Primary objective: To compare difference in composite incidence of complications of cirrhosis (Acute kidney injury, ascites, hyponatremia, hepatic encephalopathy) in patients receiving midodrine and albumin versus those receiving midodrine alone.
Secondary objectives:
- To compare the rate of control of ascites by 6 months in the 2 groups
- To compare the change in Mean arterial pressure (MAP) at 1 week, 2 weeks, 4 weeks, 3 months, and 6 months in the 2 groups
- To compare the Plasma renin activity at baseline, 4 weeks, 3mo, 6mo in the 2 groups
- Evaluate the change in serum sodium from baseline to 6 months in the 2 groups
- To compare the Creatinine from baseline to 6 months in the 2 groups
- To compare the Frequency of development of drug related adverse effects by 6 months
- To compare the Transplant free survival in the 2 groups
- To compare the Cytokines levels at baseline and 6 months in the 2 groups
- To compare the presence of Minimal Hepatic encephalopathy in the 2 groups Study population :Children and Adolescents of age group upto 18 years with decompensated cirrhosis with clinical ascites, following up in the Pediatric Hepatology Department, ILBS will be prospectively included in this study after informed consent
- Study design: Open-label Randomized Controlled Trial
- Study period: 6 months weeks for each patient; The study will be conducted from the time of ethical approval to June 2025.
Sample size: In a pilot trial done at our center comparing midodrine and SMT the composite incidence of complication was 61.2% in midodrine arm. In absence of a pediatric study we assume a 25% reduction of complication by adding albumin along with midodrine keeping a power of study 80% , the sample size was calculated to be 30 in each arm.
- Conditions
- Liver Cirrhosis
- Being tested
- Midodrine, albumin, Standard Medical Treatment
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidodrineDrug
- Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10%
albuminBiological
- Albumin infusion 1g/kg/day (max 20g) every two weeks (if pre-infusion serum albumin is < 3.5 gm/dl
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| Midodrine+Albumin+SMT | Experimental | * Albumin infusion 1g/kg/day (max 20g) every two weeks (if pre-infusion serum albumin is < 3.5 gm/dl Plus
* Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% .
In addition, standard medical therapy will be administered to patients in both the arms. Receives: Drug: Midodrine; Biological: albumin; Other: Standard Medical Treatment |
| Midodrine+SMT | Active comparator | • Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% In addition, standard medical therapy will be administered to patients in both the arms. Receives: Drug: Midodrine; Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare difference in composite incidence of complications of cirrhosis (Acute kidney injury, ascites, hyponatremia, hepatic encephalopathy) in patients receiving midodrine and albumin versus those receiving midodrine alone.
Measured: 6 months
Secondary outcomes (9)
To compare the rate of control of ascites by 6 months in the 2 groups
Measured: 6 months
To compare the change in Mean arterial pressure (MAP) at 1 week, 2 weeks, 4 weeks, 3 months, and 6 months in the 2 groups
Measured: 1 week, 2 weeks, 4 weeks, 3 months, and 6 months
To compare the Plasma renin activity at baseline, 4 weeks, 3mo, 6mo in the 2 groups
Measured: baseline, 4 weeks, 3months, 6months
Evaluate the change in serum sodium from baseline to 6 months in the 2 groups
Measured: 6 months
To compare the Creatinine from baseline to 6 months in the 2 groups
Measured: 6 months
To compare the Frequency of development of drug related adverse effects by 6 months
Measured: 6 months
To compare the Transplant free survival in the 2 groups
Measured: 6 months
To compare the Cytokines levels at baseline and 6 months in the 2 groups
Measured: 6 months
To compare the presence of Minimal Hepatic encephalopathy in the 2 groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start22 Dec 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- None (open label)
- Enrolment
- 61 participants (actual)
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
- NCT06091345
- Sponsor's protocol ID
- ILBS-Cirrhosis-65
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites - An Open Label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06091345
- Acronym / sponsor ID
- ILBS-Cirrhosis-65
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Oct 2023 (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.
Children with decompensated cirrhosis are more prone to develop various complications. The pathogenesis of cirrhotic complications (ascites, hyponatremia, acute kidney injury) includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis (RAAS) causing sodium and water retention and renal vasoconstriction.
The development of complications in these children may result in death or may preclude them from reaching upto liver transplantation.
Midodrine is an α1 adrenergic receptor agonist, which increases vascular tone causing rise in the blood pressure, thereby improving renal perfusion and causes RAAS deactivation. The effects of midodrine is documented in reduction of refractory ascites, hepatorenal syndrome and hyponatremia.
Albumin is a protien that works by both increasing the colloidal oncotic pressure and improving systemic circulation as well as by effecting the body with anti-inflammatory and antioxidant properties.
We have already demonstrated the safety and efficacy of midodrine as well as albumin in cirrhotic children. However, none of these drugs alone provided survival benefit to the patients. Hence, we have planned this study with the ojective to evaluate if combining these 2 drugs (midodrine and albumin) would further reduce the complications and improve the survival in decompensated cirrhotic children.
Detailed description
Aim: To evaluate whether a combination of midodrine and intravenous albumin reduces complications of cirrhosis in decompensated (ascites) cirrhotic children as compared to midodrine alone.
Primary objective: To compare difference in composite incidence of complications of cirrhosis (Acute kidney injury, ascites, hyponatremia, hepatic encephalopathy) in patients receiving midodrine and albumin versus those receiving midodrine alone.
Secondary objectives:
- To compare the rate of control of ascites by 6 months in the 2 groups
- To compare the change in Mean arterial pressure (MAP) at 1 week, 2 weeks, 4 weeks, 3 months, and 6 months in the 2 groups
- To compare the Plasma renin activity at baseline, 4 weeks, 3mo, 6mo in the 2 groups
- Evaluate the change in serum sodium from baseline to 6 months in the 2 groups
- To compare the Creatinine from baseline to 6 months in the 2 groups
- To compare the Frequency of development of drug related adverse effects by 6 months
- To compare the Transplant free survival in the 2 groups
- To compare the Cytokines levels at baseline and 6 months in the 2 groups
- To compare the presence of Minimal Hepatic encephalopathy in the 2 groups Study population :Children and Adolescents of age group upto 18 years with decompensated cirrhosis with clinical ascites, following up in the Pediatric Hepatology Department, ILBS will be prospectively included in this study after informed consent
- Study design: Open-label Randomized Controlled Trial
- Study period: 6 months weeks for each patient; The study will be conducted from the time of ethical approval to June 2025.
Sample size: In a pilot trial done at our center comparing midodrine and SMT the composite incidence of complication was 61.2% in midodrine arm. In absence of a pediatric study we assume a 25% reduction of complication by adding albumin along with midodrine keeping a power of study 80% , the sample size was calculated to be 30 in each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midodrine+Albumin+SMT | Experimental | Drug: Midodrine, Biological: albumin, Other: Standard Medical Treatment* Albumin infusion 1g/kg/day (max 20g) every two weeks (if pre-infusion serum albumin is < 3.5 gm/dl Plus * Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% . In addition, standard medical therapy will be administered to patients in both the arms. |
| Midodrine+SMT | Active comparator | Drug: Midodrine, Other: Standard Medical Treatment• Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% In addition, standard medical therapy will be administered to patients in both the arms. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children (≤ 18 years)
- Cirrhosis based on histological/ radiological + endoscopic evidence
- Clinical ascites (≥ grade 2 ascites)
- Informed consent from parents (Assent > 12 years)
Key exclusion criteria (8 listed)
- Arterial hypertension (Mean Arterial Pressure ≥ 95th centile for age)
- Presence of Portal vein thrombosis
- Hepatorenal Syndrome
- Congestive Heart failure
- Respiratory failure(PF ratio <200)
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• Midodrine starting at 0.25mg/kg/day in divided doses, increased to 0.5mg/kg/day after 7 days if MAP does not increase by >10% | Drug | Midodrine+Albumin+SMT, Midodrine+SMT |
| albumin• Albumin infusion 1g/kg/day (max 20g) every two weeks (if pre-infusion serum albumin is < 3.5 gm/dl | Biological | Midodrine+Albumin+SMT |
| Standard Medical TreatmentStandard Medical Treatment | Other | Midodrine+Albumin+SMT, Midodrine+SMT |
Primary outcome
To compare difference in composite incidence of complications of cirrhosis (Acute kidney injury, ascites, hyponatremia, hepatic encephalopathy) in patients receiving midodrine and albumin versus those receiving midodrine alone.
Time frame: 6 months
9 secondary outcomes
To compare the rate of control of ascites by 6 months in the 2 groups
Time frame: 6 months
To compare the change in Mean arterial pressure (MAP) at 1 week, 2 weeks, 4 weeks, 3 months, and 6 months in the 2 groups
Time frame: 1 week, 2 weeks, 4 weeks, 3 months, and 6 months
To compare the Plasma renin activity at baseline, 4 weeks, 3mo, 6mo in the 2 groups
Time frame: baseline, 4 weeks, 3months, 6months
Evaluate the change in serum sodium from baseline to 6 months in the 2 groups
Time frame: 6 months
To compare the Creatinine from baseline to 6 months in the 2 groups
Time frame: 6 months
To compare the Frequency of development of drug related adverse effects by 6 months
Time frame: 6 months
To compare the Transplant free survival in the 2 groups
Time frame: 6 months
To compare the Cytokines levels at baseline and 6 months in the 2 groups
Time frame: 6 months
To compare the presence of Minimal Hepatic encephalopathy in the 2 groups
Time frame: 6 months
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 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midodrine, albumin and Standard Medical Treatment in people with Liver Cirrhosis, 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 4 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 Mar 2026. 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?
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?
To compare difference in composite incidence of complications of cirrhosis (Acute kidney injury, ascites, hyponatremia, hepatic encephalopathy) in patients receiving midodrine and albumin versus those receiving midodrine alone. (time frame: 6 months). 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 10 Mar 2026.