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A prospective, randomized, controlled, double-blind clinical trial for intravenous high-dose vitamin C on acute pancreatits

Protective effect of high dose Vitamin C on the multi organs function in moderately severe/severe acute pancreatitis: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022022
Enrollment
Unknown
Registered
2019-03-21
Start date
2019-04-01
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Interventions

Vit C group:continuos intravenous injection of Vitamin C with 200 mg/kg/h for 7 days
NS group:continuos intravenous injection of normal saline using the same dose as Vit C for 7days

Sponsors

Department of emergency, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Onset within 72 hours; 3. Meeting the diagnostic criteria for acute pancreatitis(meeting 2 of the following 3 features); (1) Abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back); (2) Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal; (3) Characteristic findings of acute pancreatitis on contrast-enhanced computed tomography (CECT) and magnetic resonance imaging (MRI). 4. Meeting the grades of severity for moderately severe/severe acute pancreatitis (1) Moderately severe acute pancreatitis: Organ failure that resolves within 48 h (transient organ failure) and/or local or systemic complications without persistent organ failure A.Definition of organ failure and systemic cmplications: Respiratory: PaO2/FiO2=300; Cardiovascular: systolic blood pressure=90 mm Hg (off inotropic support), not fluid responsive or PH48 h) 5. Sign the consent.

Exclusion criteria

Exclusion criteria: 1. In the period of pregnant or lactation; 2. Pancreatits resulting from malignant tumor or ERCP; 3. Be allergic to Vitamin C; 4. With severe chronic dysfunction of heart, liver, lung, renal or blood system before admission; 5. With kidney stone; 6. Uncured malignant tumor; 7. With autoimmune disease or immunosuppressive state (having accepted solid organs or bone marrow transplantation, AIDS, long-term use of immunosuppressive agents or hormones, etc.); 8. With some special device (eg. pacemaker); 9. Involved in other clinical trial.

Design outcomes

Primary

MeasureTime frame
28 days mortality;

Secondary

MeasureTime frame
indication for organ function(liver,kidney,heart,lung,coagulation);sequential organ failure assessment (SOFA) score,acute physiology and chronic health evaluation II ( APACHEII ) score;VitC related adverse event(urine crystal,urine volume per day,indicatiors for kidney function);period for ventilation;period for renal replacement therapy;period for vasoactive agents application;time and procedure of surgical intervention;90 days mortality;ROS, RNS, 8-OHdG, MDA, GSH;TNF-a, IL-6, IL-10;plasma level of VitaminC;

Countries

China

Contacts

Public ContactChen Ying

Department of emergency, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

bichatlion@163.com+86 13917403313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026