Acute-on-Chronic Liver Failure (ACLF)VITAKI-ACLFNCT07184866
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
A study testing Vitamin C in people with Acute-on-Chronic Liver Failure (ACLF), run by Institute of Liver and Biliary Sciences, India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute-on-Chronic Liver Failure (ACLF)
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.
Who cannot join
- • Refractory Septic shock with more than 3 organ failures.
- Patients with age less than 18 years
- Known severe cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD)
- Patients in DIC with platelets < 20,000 and INR > 4 or active bleeding
- Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" (DNI) status
- Current hospitalization > 15 days for patients with nosocomial acquisition of MDR at time of randomization
Show all 19Show fewer
- Known allergy or contraindication to vitamin C (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion,
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
- Use of vitamin C at a dose of > 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission
- Patients with HCC (beyond Milan) or extrahepatic malignancies
- Patients with HVOTO or EHPVO
- Pregnancy or active breastfeeding
- Current participation in another interventional research study
- Active or history of kidney stones
- History of chronic kidney disease or intrinsic kidney disease
- Patients already on maintenance hemodialysis prior to presentation
- Failure to provide informed consent
- Patients with retroviral infection
- Patients with active hemolysis due to alcohol or other causes or with hemoglobin below 7 gm/dl
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial Open Label Evaluating the Efficacy of Vitamin C in Improving Outcomes of Acute Kidney Injury in Patients With ACLF With Septic Shock
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:
Read more
- Standard medical treatment alone, or
- Standard medical treatment plus intravenous Vitamin C.
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.
Read the detailed description
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.
- Conditions
- Acute-on-Chronic Liver Failure (ACLF)
- Being tested
- Vitamin C, Standard of Care (SOC)
- Keywords
- Sepsis, septic shock, Alcohol-related, ACLF, AKI, Lactate, Vitamin
- Medical subject headings
- Acute-On-Chronic Liver Failure, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called (Ascorbic Acid)
Intravenous Vitamin C, 25 mg/kg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of Care (SOC) |
| 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 Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 4 (96 hours) after randomization
Secondary outcomes (7)
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.
Measured: Day 7
Incidence of adverse events
Number and type of adverse events including hypotension, sepsis, bleeding, allergic reactions, anemia, kidney stones, urinary oxalate, hemolysis, and thrombocytopenia.
Measured: 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.
Measured: Day 7
Duration of ICU stay
Number of days spent in ICU from randomization to discharge or death.
Measured: Through hospital discharge or death, up to 28 days
Duration of hospital stay
Total number of days from admission to discharge or death.
Measured: Up to Day 28
7-day mortality
All-cause mortality within 7 days of randomization
Measured: Day 7
28-day mortality
All-cause mortality within 28 days of randomization
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start15 Dec 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (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 Failure (ACLF)Studies 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
- 110 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
- NCT07184866
- Sponsor's protocol ID
- IEC/2024/116/MA02
- Other IDs
- IEC approval number
- Acronym
- VITAKI-ACLF
- Status last verified
- Nov 2026
- First submitted
- 13 Sep 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Open Label Evaluating the Efficacy of Vitamin C in Improving Outcomes of Acute Kidney Injury in Patients With ACLF With Septic Shock
- ClinicalTrials.gov ID
- NCT07184866
- Acronym / sponsor ID
- VITAKI-ACLF / IEC/2024/116/MA02
- Conditions
- Acute-on-Chronic Liver Failure (ACLF)
- Keywords
- Sepsis, septic shock, Alcohol-related, ACLF, AKI, Lactate, Vitamin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Sep 2025 (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.
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:
- Standard medical treatment alone, or
- Standard medical treatment plus intravenous Vitamin C.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Other: Standard of Care (SOC)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 | Drug: Vitamin CParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACLF as per asia pacific association for the study of liver (APASL criteria) with AKI according to KDIGO Criteria and septic shock.
Key exclusion criteria (19 listed)
- • Refractory Septic shock with more than 3 organ failures.
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 |
|---|---|---|
| Vitamin CAlso: (Ascorbic Acid)Intravenous Vitamin C, 25 mg/kg (maximum 1.5 g) every 6 hours for 5 days, administered in addition to standard medical treatment | Drug | Vitamin C + Standard of Care |
| Standard of Care (SOC)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 | Other | Standard of Care (SOC) |
Primary outcome
Resolution of septic shock at 96 hours (Day 4)
Time frame: Day 4 (96 hours) after randomization
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.
7 secondary outcomes
Outcome of acute kidney injury (AKI) at Day 7
Time frame: Day 7
Incidence of adverse events
Time frame: Day 7, Day 14, Day 28 or until hospital discharge, whichever occurs first
Need for renal replacement therapy
Time frame: Day 7
Duration of ICU stay
Time frame: Through hospital discharge or death, up to 28 days
Duration of hospital stay
Time frame: Up to Day 28
7-day mortality
Time frame: Day 7
28-day mortality
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Acute-on-Chronic Liver Failure (ACLF)
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Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
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RENEW: Study of Porcine Liver Support in Participants With Acute-on-Chronic Liver Failure
Acute on Chronic Liver Failure (ACLF), Hepatic Encephalopathy (HE)
RecruitingPhase 2
A-TANGO Phase 2 Study
Acute-On-Chronic Liver Failure, Alcoholic Hepatitis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Acute-on-Chronic Liver Failure (ACLF), run by Institute of Liver and Biliary Sciences, 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 19 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Rakhi Maiwall, MBBS, MD, DM (+91 8750343085, rakhi_2011@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of septic shock at 96 hours (Day 4) (time frame: Day 4 (96 hours) after randomization). 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 6 Nov 2026.