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A clinical trial comparing the effects of balanced salt solution and normal saline on organ function in patients with severe acute pancreatitis: A multicenter, cluster randomized, cross-controlled trial

A clinical trial comparing the effects of balanced salt solution and normal saline on organ function in patients with severe acute pancreatitis: A multicenter, cluster randomized, cross-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125875
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Acute pancreatitis

Interventions

Balanced salt group:Patients randomly assigned to the balanced salt group will make the maximum use of balanced salt solutions (lactate Ringer's solution, acetic acid Ringer's solution, and carbonate
Normal saline group:Patients randomly assigned to the normal saline group will use normal saline to the maximum extent for all intravenous fluid treatments before death, before discharge, or within 7

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.The symptoms and signs of acute pancreatitis based on abdominal pain suggest AP, serum amylase is at least three times the upper limit of normal, and/or there are characteristic imaging manifestations of AP on CT. 2. Within 48 hours after the onset of the disease; 3. Aged between 18 and 70; 4. SIRS or CRP>150mg/L was present at the time of enrollment

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant or breastfeeding at the time of registration; 2. Received percutaneous drainage or surgery before admission, or required early surgery due to abdominal syndrome, etc. 3. Patients who had undergone CRRT before admission; 4. Patients who require emergency CRRT upon admission (with life-threatening water, salt, and acid-base imbalances); 5. The patient presents with respiratory failure, severe systemic circulatory failure, coma or other irreversible dangerous symptoms, and is expected to die within 24 hours (systolic blood pressure < 90mmHg and serum pH< 7.0 under full fluid resuscitation and treatment with 25ml/min or higher doses of norepinephrine); 6. Patients with a known history of severe cardiovascular, respiratory, renal, liver, blood or immune diseases are defined as (1) having a New York Heart Association grade II heart failure, (2) active myocardial ischemia or (3) cardiovascular intervention within the past 60 days, (4) a history of liver cirrhosis or (5) chronic kidney disease with a creatinine clearance rate of less than 40 mL/min. Or (6) Chronic obstructive pulmonary disease that requires home oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Survival within 7 days without organ failure days;

Secondary

MeasureTime frame
No organ failure within 14 days and the number of days of survival;MAKE30;The proportion of patients requiring admission to the ICU;The number of days without an ICU within 30 days;There are no mechanical ventilation days within 30 days;The number of days without vasoactive drugs within 30 days;There are no days of renal replacement therapy within 30 days;New organ dysfunction occurred after enrollment;The SOFA2 score from day 1 to day 7;The incidence of pancreatic infection and necrosis (IPN) during admission;

Countries

China

Contacts

Public ContactJianfeng Tu

Zhejiang Provincial People's Hospital

ZRY-AP@hotmail.com+86 159 2566 9920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026