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Fluid resuscitation via colon in the early stage of severe acute pancreatitis: a multicenter randomized controlled study

Fluid resuscitation via colon in the early stage of severe acute pancreatitis: a multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078427
Enrollment
Unknown
Registered
2023-12-07
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Severe acute pancreatitis

Interventions

Fluid resuscitation via colon group:Fluid resuscitation via colon
Intravenous fluid resuscitation group:Intravenous fluid resuscitation

Sponsors

Ruijin hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) First onset of illness, admitted within 72 hours after onset. 2) Diagnosed with acute pancreatitis within 24 hours of admission: upper abdominal pain; plasma amylase level elevated more than 3 times the upper limit of normal; imaging evidence of acute pancreatitis. Meet 2 or more of the following criteria. 3) Moderate-severe acute pancreatitis: clinical manifestations and biochemical changes of acute pancreatitis, accompanied by transient organ failure (Modified Marshall score = 2 points, recoverable within 48 hours), or accompanied by local or systemic complications. Severe acute pancreatitis: clinical manifestations and biochemical changes of acute pancreatitis, accompanied by persistent (>48 hours) organ dysfunction, Modified Marshall score = 2 points. 4) Age = 18 years, = 75 years. 5) Meet 2 or more of the following criteria: heart rate = 120 bpm; MAP 85 mmHg; urine output = 0.5 ml/kg/h; HCT > 44%. 6) Informed consent has been obtained.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this study: 1) Previous episodes of pancreatitis or a history of chronic pancreatitis. 2) Diagnosis of pancreatitis more than 24 hours after admission or admission more than 72 hours after the onset of symptoms. 3) Pancreatitis caused by malignant tumors or ERCP. 4) Pregnancy or lactation. 5) Patients or their proxies refusing active organ support measures such as renal replacement therapy, vasopressor medications, and mechanical ventilation. 6) Pre-existing chronic organ failure in the heart, liver, lungs, or kidneys; long-term use of left ventricular assist devices or potent cardiac drugs like milrinone; Child-Pugh class C or D liver function; chronic respiratory failure requiring long-term home non-invasive oxygen therapy (nasal cannula or non-invasive positive pressure ventilator); diagnosed chronic kidney disease with a sustained eGFR 150 umol/L. 7) Use of immunosuppressive agents or corticosteroids exceeding two weeks (equivalent to prednisone or methylprednisolone at a dose of 0.5 mg/kg/day), including various autoimmune diseases and organ transplantation. 8) Patient and family refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
28-day mortality;

Secondary

MeasureTime frame
Heart rate;blood pressure;urine volume;Intake and exit volume;intra-abdominal pressure;blood routine;electrolyte;lactic acid;hematocrit;Liver function;kidney function;Myocardial zymogram;arterial blood gas analysis;Coagulation function indicators;immune indicators;C-reactive protein;Procalcitonin;Stool routine;Urine routine;

Countries

China

Contacts

Public ContactTongtian Ni

Ruijin hospital, Shanghai Jiao Tong University School of Medicine

topntt@126.com+86 137 6455 0263

Outcome results

None listed

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