Severe Acute PancreatitisNCT06897384
High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis
A study testing Saline (NaCl 0,9 %) and Vitamin C (Ascorbic Acid) in people with Severe Acute Pancreatitis, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is a prospective, randomized, double-blinded, parallel-controlled, multi-central clinical trial for patients with severe acute pancreatitis (SAP). Patients with SAP in the early stage (within 7 days of onset) and over the age of 18, based on the routine treatment, will be randomly divided into a high-dose… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Acute Pancreatitis
- What is being tested?
- Saline (NaCl 0,9 %) and Vitamin C (Ascorbic Acid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Time from onset of illness to enrollment is less than 7 days
- Meet the 2012 Atlanta Guidelines SAP diagnostic criteria
Who cannot join
- SAP caused by tumors or ERCP
- Pregnant or breastfeeding
- Allergic to vitamin C
- Use of other experimental drugs within the timeframe of this study
- Chronic organs failure such as heart, liver, lung, or kidney before admission, with specific indicators being (chronic cardiovascular dysfunction requiring long-term mechanical hemodynamic support or inotropic drug support; chronic obstructive pulmonary disease requiring home oxygen therapy; chronic liver dysfunction at Child-Pugh Class C; chronic kidney disease with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m² or serum creatinine greater than 150 μmol/L)
- Immunosuppressed state, including malignant tumors, post-transplant status, long-term use of immunosuppressor (for at least 1 month before enrollment), AIDS, etc.
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- The patient and family are unwilling to sign the informed consent form
- Body weight greater than 100kg
- Urinary system stones
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
Shanghai, Shanghai Municipality
About this study
This study is a prospective, randomized, double-blinded, parallel-controlled, multi-central clinical trial for patients with severe acute pancreatitis (SAP). Patients with SAP in the early stage (within 7 days of onset) and over the age of 18, based on the routine treatment, will be randomly divided into a high-dose intravenous vitamin C group (HDIVC, 500mg/kg/24h, administered by iv. pump at a rate of 2g/h for 7 days) and a control group (an equal volume of normal saline). The primary endpoint is mortality rate in ICU, and secondary endpoints include free organ support duration (FOSD) within 14 days after enrollment, changes in inflammatory response and severity, disease severity scores and changes, fluid retention, incidence of infectious pancreatic necrosis (IPN), ICU mortality, pancreatic necrosis scores, monitoring of vitamin C plasma concentrations before and after HDIVC use, composition of gut microbiota, observation of vitamin C-related adverse reactions. The study hypothesis is that HDIVC can reduce mortality rate in ICU, significantly decrease the FOSD within 14 days and significantly reduce inflammatory response, decrease fluid retention, and improve disease severity.
- Conditions
- Severe Acute Pancreatitis
- Being tested
- Saline (NaCl 0,9 %), Vitamin C (Ascorbic Acid)
- Keywords
- high-dose intravenous vitamin C, severe acute pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline (NaCl 0,9 %)Drug
The control group involves only adding 50ml of normal saline to a 50ml syringe, without any labels to ensure identical appearance, and the method of administration and dosage are the same with vitamin C group.
Vitamin C (Ascorbic Acid)Drug
Also called Vitamin C group
Vitamin C at dose of 500mg/kg/24h, 2g/h
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C Group | Experimental | The intervention is the administration of vitamin C via central venous infusion at a rate of 500mg/kg/24h, 2g/h, for a total of 7 days. Receives: Drug: Vitamin C (Ascorbic Acid) |
| Control Group | Placebo comparator | The intervention for the control group involves administering the same dosage of normal saline via the same injection method for a total of 7 days. Receives: Drug: Saline (NaCl 0,9 %) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate in ICU
Measured: through study completion, an average of 6 months
Secondary outcomes (15)
The Impact of HDIVC on Free Organ Support Duration (FOSD) within 14 Days of Enrollment
Measured: 14 days of enrollment
The Impact of HDIVC on Early Inflammatory Markers in SAP, Including the Levels and Changes of C-Reactive Protein and Inflammatory Cytokines IL-6, IL-1, and IL-10
Measured: 28 days of enrollment
the Duration of Systemic Inflammatory Response Syndrome (SIRS)
The scoring system primarily includes the following four clinical indicators. If ≥2 criteria are met, SIRS can be diagnosed:
- Temperature >38°C or <36°C
- Heart Rate>90 beats per minute
- Respiratory rate >20 breaths per minute, or arterial PaCO₂ <32 mmHg
- Abnormal White Blood Cell (WBC) Count >12×10⁹/L or <4×10⁹/L, or immature neutrophils >10%
Measured: 28 days of enrollment
The Impact of HDIVC on Sequential Organ Failure Assessment (SOFA) Score
The SOFA score involves six major organ systems, including the respiratory system, hematologic system (platelets), liver function, renal function, central nervous system, and circulatory system (blood pressure). Each system is scored from 0 to 4, with a total score ranging from 0 to 24. Higher scores indicate that the organ failure is more severe.
Measured: 28 days of enrollment
The Impact of HDIVC on Modified Marshall Score
This scoring system primarily evaluates three key organ systems (respiratory system, circulatory system and renal function), with each system scored from 0 to 4. If any system scores ≥2, organ dysfunction is considered present.
Measured: 28 days of enrollment
The Impact of HDIVC on Fluid Retention
assessment of fluid retention, defined as the total input volume of intravenous fluid and enteral nutrition minus the output volume of urine and drainage
Measured: 28 days of enrollment
The Impact of HDIVC on Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
It is a severity-of-disease classification system used to assess critically ill patients and predict hospital mortality. The score is calculated based on three main components: Acute Physiology Score (APS) (0-60 points), Age Score (0-6 points) and Chronic Health Condition Score (0-5 points). It has a maximum total score of 71 points. The higher the APACHE II score, the greater the risk of mortality.
Measured: 28 days of enrollment
The Impact of HDIVC on Bedside Index for Severity in Acute Pancreatitis (BISAP) Score
It is a scoring system used for early assessment of disease severity and prognosis in patients with acute pancreatitis (AP). Each item scores 1 point, total 0-5 points.
B - BUN > 25 mg/dL (Blood Urea Nitrogen > 25 mg/dL) I - Impaired mental status (Glasgow Coma Scale [GCS] < 15) S - SIRS (Systemic Inflammatory Response Syndrome) (Meeting ≥2 criteria) A - Age > 60 years P - Pleural effusion BISAP helps predict mortality risk and complications.0-1 points means very low mortality risk (<1%). 2-3 points means moderate risk (mortality rate ~2-10%). 4-5 points means high risk (mortality rate >20%).
Measured: 28 days of enrollment
The Impact of HDIVC on Pancreatic Necrosis, namely Computed Tomography Severity Index (CTSI).
It is a scoring system used to assess the severity of acute pancreatitis (AP) based on contrast-enhanced CT (CECT) imaging. CTSI helps predict disease severity, complications, and prognosis. It categorizes acute pancreatitis severity as follows:
0-3 points: Mild pancreatitis, low risk of complications 4-6 points: Moderate pancreatitis, higher risk of complications and organ failure 7-10 points: Severe pancreatitis, high risk of necrosis, organ failure, and mortality
Measured: 28 days of enrollment
The Incidence of IPN (Infection-Related Pancreatic Necrosis)
Measured: 28 days of enrollment
ICU Stay Duration
Measured: through study completion, an average of 6 months
Hospitalization Costs
Measured: through study completion, an average of 6 months
Plasma Concentration of Vitamin C Before and After Treatment
Measured: 28 days of enrollment
Adverse events related to Vitamin C
Measured: 28 days of enrollment
The Impact of HDIVC on the Composition of the Gut Microbiota
The study use the fecal sample to assess the composition of gut microbiota using sequencing techniques (16S rRNA, metagenomics), diversity analysis (alpha and beta diversity), functional profiling (metabolomics) and inflammation markers (calprotectin).
Measured: 28 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897384
- Sponsor's protocol ID
- 2024430
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao B, Yu X, Zhang H, Yu M, Sun W, Zhao F, Huang H, Song M, Wang S, Ma W, Shen M, Zhao S, Wang Y, Gui M, Xu D, Gao M, Sheng H, Ma L, Jiang W, Ning N, Sun S, Li Y, Hu Q, Liu X, Zhou P, Tao Y, Huang J, Zeng Y, Wang M, Wang R, Mao E. Effect of high-dose intravenous vitamin C on organ support-free days within the first 14 days in severe acute pancreatitis patients: a multicenter, randomized, double-blind, placebo-controlled clinical trial protocol. Front Nutr. 2026 Aug 6;13:1850105. doi: 10.3389/fnut.2026.1850105. eCollection 2026.
PubMed 42625618
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT06897384
- Acronym / sponsor ID
- 2024430
- Conditions
- Severe Acute Pancreatitis
- Keywords
- high-dose intravenous vitamin C, severe acute pancreatitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Mar 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 a prospective, randomized, double-blinded, parallel-controlled, multi-central clinical trial for patients with severe acute pancreatitis (SAP). Patients with SAP in the early stage (within 7 days of onset) and over the age of 18, based on the routine treatment, will be randomly divided into a high-dose intravenous vitamin C group (HDIVC, 500mg/kg/24h, administered by iv. pump at a rate of 2g/h for 7 days) and a control group (an equal volume of normal saline). The primary endpoint is mortality rate in ICU, and secondary endpoints include free organ support duration (FOSD) within 14 days after enrollment, changes in inflammatory response and severity, disease severity scores and changes, fluid retention, incidence of infectious pancreatic necrosis (IPN), ICU mortality, pancreatic necrosis scores, monitoring of vitamin C plasma concentrations before and after HDIVC use, composition of gut microbiota, observation of vitamin C-related adverse reactions. The study hypothesis is that HDIVC can reduce mortality rate in ICU, significantly decrease the FOSD within 14 days and significantly reduce inflammatory response, decrease fluid retention, and improve disease severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C Group | Experimental | Drug: Vitamin C (Ascorbic Acid)The intervention is the administration of vitamin C via central venous infusion at a rate of 500mg/kg/24h, 2g/h, for a total of 7 days. |
| Control Group | Placebo comparator | Drug: Saline (NaCl 0,9 %)The intervention for the control group involves administering the same dosage of normal saline via the same injection method for a total of 7 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Time from onset of illness to enrollment is less than 7 days
- Meet the 2012 Atlanta Guidelines SAP diagnostic criteria
Key exclusion criteria (9 listed)
- SAP caused by tumors or ERCP
- Pregnant or breastfeeding
- Allergic to vitamin C
- Use of other experimental drugs within the timeframe of this study
- Chronic organs failure such as heart, liver, lung, or kidney before admission, with specific indicators being (chronic cardiovascular dysfunction requiring long-term mechanical hemodynamic support or inotropic drug support; chronic obstructive pulmonary disease requiring home oxygen therapy; chronic liver dysfunction at Child-Pugh Class C; chronic kidney disease with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m² or serum creatinine greater than 150 μmol/L)
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 |
|---|---|---|
| Saline (NaCl 0,9 %)The control group involves only adding 50ml of normal saline to a 50ml syringe, without any labels to ensure identical appearance, and the method of administration and dosage are the same with vitamin C group. | Drug | Control Group |
| Vitamin C (Ascorbic Acid)Also: Vitamin C groupVitamin C at dose of 500mg/kg/24h, 2g/h | Drug | Vitamin C Group |
Primary outcome
Mortality rate in ICU
Time frame: through study completion, an average of 6 months
15 secondary outcomes
The Impact of HDIVC on Free Organ Support Duration (FOSD) within 14 Days of Enrollment
Time frame: 14 days of enrollment
The Impact of HDIVC on Early Inflammatory Markers in SAP, Including the Levels and Changes of C-Reactive Protein and Inflammatory Cytokines IL-6, IL-1, and IL-10
Time frame: 28 days of enrollment
the Duration of Systemic Inflammatory Response Syndrome (SIRS)
Time frame: 28 days of enrollment
The Impact of HDIVC on Sequential Organ Failure Assessment (SOFA) Score
Time frame: 28 days of enrollment
The Impact of HDIVC on Modified Marshall Score
Time frame: 28 days of enrollment
The Impact of HDIVC on Fluid Retention
Time frame: 28 days of enrollment
The Impact of HDIVC on Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Time frame: 28 days of enrollment
The Impact of HDIVC on Bedside Index for Severity in Acute Pancreatitis (BISAP) Score
Time frame: 28 days of enrollment
The Impact of HDIVC on Pancreatic Necrosis, namely Computed Tomography Severity Index (CTSI).
Time frame: 28 days of enrollment
The Incidence of IPN (Infection-Related Pancreatic Necrosis)
Time frame: 28 days of enrollment
ICU Stay Duration
Time frame: through study completion, an average of 6 months
Hospitalization Costs
Time frame: through study completion, an average of 6 months
Plasma Concentration of Vitamin C Before and After Treatment
Time frame: 28 days of enrollment
Adverse events related to Vitamin C
Time frame: 28 days of enrollment
The Impact of HDIVC on the Composition of the Gut Microbiota
Time frame: 28 days of enrollment
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 26 Mar 2025.
- Derived from this study: PubMed 42625618Zhao B, Yu X, Zhang H, Yu M, Sun W, Zhao F, Huang H, Song M, Wang S, Ma W, Shen M, Zhao S, Wang Y, Gui M, Xu D, Gao M, Sheng H, Ma L, Jiang W, Ning N, Sun S, Li Y, Hu Q, Liu X, Zhou P, Tao Y, Huang J, Zeng Y, Wang M, Wang R, Mao E. Effect of high-dose intravenous vitamin C on organ support-free days within the first 14 days in severe acute pancreatitis patients: a multicenter, randomized, double-blind, placebo-controlled clinical trial protocol. Front Nutr. 2026 Aug 6;13:1850105. doi: 10.3389/fnut.2026.1850105. eCollection 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 Saline (NaCl 0,9 %) and Vitamin C (Ascorbic Acid) in people with Severe Acute Pancreatitis, run by Ruijin Hospital at 1 site in China.
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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
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?
Mortality rate in ICU (time frame: through study completion, an average of 6 months). 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 NCT06897384, which also lists 1 linked publication.
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 26 Mar 2025.