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| ID | Type | Description | Link |
|---|---|---|---|
| IEC approval number | Other Identifier | Institute of Liver and Biliary Sciences |
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This study is testing whether Vitamin C can help improve kidney function and survival in very sick patients with liver disease. Patients with acute-on-chronic liver failure (ACLF) often develop serious infections that can lead to septic shock and kidney injury, which are major causes of death.
In this randomized controlled trial, patients with ACLF and septic shock will be assigned to receive either:
Vitamin C is a safe, inexpensive antioxidant that may reduce inflammation, improve circulation, and protect the kidneys. The study will compare how well patients recover from septic shock and kidney injury in the two groups. Blood and urine samples will also be collected to look for biological markers that can predict outcomes.
Acute-on-chronic liver failure (ACLF) is a severe condition in which patients with chronic liver disease suddenly develop liver failure, often triggered by infection. Many of these patients progress to septic shock, and acute kidney injury (AKI) is a common and life-threatening complication. Current treatment options are limited, and mortality remains very high.
Vitamin C is a low-cost, widely available antioxidant and immune-modulating agent. It has shown promising results in patients with sepsis and septic shock by reducing oxidative stress, improving vascular tone, and supporting immune defense. However, its role in ACLF patients with septic shock and AKI has not been studied in a large, controlled trial.
This interventional, randomized, open-label controlled trial will enroll patients with alcohol-related ACLF, septic shock, and AKI. Participants will be randomized 1:1 to receive either intravenous Vitamin C in addition to standard medical care, or standard care alone. Clinical outcomes, including resolution of shock, progression or resolution of AKI, need for renal replacement therapy, ICU/hospital stay, and survival at 7 and 28 days will be assessed. In addition, biospecimens (blood and urine) will be analyzed to identify biomarkers that predict outcomes and response to Vitamin C therapy.
The study aims to provide evidence on the effectiveness of Vitamin C as an adjunctive therapy in this high-risk population, and to generate insights into the mechanisms of septic shock and kidney injury in ACLF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care (SOC) | Active Comparator | Participants in this arm will receive standard medical treatment for ACLF with septic shock and acute kidney injury, as per institutional protocols. |
|
| Vitamin C + Standard of Care | Experimental | Participants in this arm will receive intravenous Vitamin C (25 mg/kg, up to 1.5 g every 6 hours for 5 days) in addition to standard medical treatment for ACLF with septic shock and acute kidney injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Intravenous Vitamin C, 25 mg/kg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of septic shock at 96 hours (Day 4) | Resolution of septic shock is defined as maintenance of mean arterial pressure (MAP) ≥ 65 mmHg for ≥ 6 consecutive hours after complete discontinuation of all vasopressor support, without restarting vasopressors during that 6-hour period. | Day 4 (96 hours) after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome of acute kidney injury (AKI) at Day 7 | AKI resolution (decrease in stage by ≥1 or return to no AKI), persistence (same stage), or progression (increase in stage by ≥1 or need for dialysis in stage 3 patients), defined by KDIGO criteria. | Day 7 |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
• Refractory Septic shock with more than 3 organ failures.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rakhi Maiwall, MBBS, MD, DM | Contact | +91 8750343085 | rakhi_2011@yahoo.co.in |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Standard of Care (SOC) | Other | Supportive and guideline-based management of ACLF with septic shock and AKI, including antibiotics, fluids, vasopressors, renal replacement therapy as required, and other standard therapies |
|
Number and type of adverse events including hypotension, sepsis, bleeding, allergic reactions, anemia, kidney stones, urinary oxalate, hemolysis, and thrombocytopenia. |
| Day 7, Day 14, Day 28 or until hospital discharge, whichever occurs first |
| Need for renal replacement therapy | Proportion of patients requiring initiation of renal replacement therapy. | Day 7 |
| Duration of ICU stay | Number of days spent in ICU from randomization to discharge or death. | Through hospital discharge or death, up to 28 days |
| Duration of hospital stay | Total number of days from admission to discharge or death. | Up to Day 28 |
| 7-day mortality | All-cause mortality within 7 days of randomization | Day 7 |
| 28-day mortality | All-cause mortality within 28 days of randomization | Day 28 |
| D004066 |
| Digestive System Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |