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oXiris versus conventional CRRT in the treatment of early severe pancreatitis with abdominal hypertension: a multicenter randomized controlled clinical trial

oXiris versus conventional CRRT in the treatment of early severe pancreatitis with abdominal hypertension: a multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048745
Enrollment
Unknown
Registered
2021-07-15
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-28

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

Conditions

early severe pancreatitis with abdominal hypertension

Interventions

experience group:Using oXiris filter
Control group:Use normal filter

Sponsors

Shenzhen Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the Atlanta criteria for pancreatitis and meet 2 of the following criteria: abdominal pain features of pancreatitis; serum amylase or lipase >= 3 times the upper limit of normal; CT scan consistent with pancreatitis features; 2. Meet the criteria for severe acute pancreatitis: organ failure and/or local pancreatic complications based on the diagnosis of pancreatitis; Ranson score >= 3 or APACHE II score >= 8; 3. Patients classified as IAP grade III (21-25 mmHg) and IV (> 25 mmHg) according to the World Abdominal Compartment Syndrome (WSACS) grading system; 4. The patient's renal function reaches KDIGO AKI grade two; 5. Aged 18 to 75 years old; 6. The patient and/or family members agree and sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. If there is obvious circulatory failure during the study, after consultation and discussion with relevant experts in the hospital, decide whether to change the plan, and communicate with the patients and their families about the best plan. If the patients and/or family members still request to withdraw, they can withdraw from the study; 2. If the patient requests to withdraw from this research during the treatment, he can withdraw from the research project and use other treatment methods for CRRT treatment; 3. Patients whose treatment time is less than 24 hours, no endpoint events and adverse reactions are observed, and CRRT is terminated due to unplanned reasons such as adjustment of doctor's orders; 4. Pregnant women are not included in the study; 5. Patients who underwent abdominal surgery within 72 hours.

Design outcomes

Primary

MeasureTime frame
The value of bladder pressure drop 72 hours after receiving treatment;

Secondary

MeasureTime frame
Time to normal bladder pressure;Changes in oxygenation index 72 hours after treatment;Changes in the dose of noradrenaline 72 hours after treatment;28 days without vasoactive drugs;Changes in lactic acid concentration 72 hours after treatment;28-day all-cause mortality;Days of mechanical ventilation;ICU hospitalization days;The number of days in hospital;Adverse events within 28 days;Inflammatory factors;

Countries

China

Contacts

Public ContactLiu Yong

Shenzhen Hospital, Southern Medical University

liuyongjoy@outlook.com+86 13928415176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026