Intra-abdominal Hypertension, Severe Acute Pancreatitis
Conditions
Keywords
Da-Cheng-Qi Decoction, traditional Chinese medicine, intra-abdominal pressure, paralytic ileus
Brief summary
This single-center prospective randomized controlled trial evaluated Da-Cheng-Qi Decoction (DCQD) as the acute-stage intervention of an integrated traditional Chinese and Western medicine whole-stage treatment protocol for severe acute pancreatitis (SAP). Sixty adults with SAP and intra-abdominal hypertension (IAP ≥ 12 mmHg) were randomized within 72 h of onset to receive standard Western treatment plus DCQD (100 mL via nasogastric tube twice daily for 7 days) or standard Western treatment alone. The primary outcome was intra-abdominal pressure measured by standardized bladder manometry every 12 h for 7 days. Secondary outcomes included stool output, length of hospital and ICU stay, and 28-day mortality. The trial was conducted at the Emergency Intensive Care Unit of Ruijin Hospital between April 2026 and July 2026.
Detailed description
Rationale: DCQD, recorded in the Shang Han Lun, is a classical purgative formula. This trial is the acute-stage component of the "Integrated Traditional Chinese and Western Medicine Whole-Stage Treatment Protocol for SAP" (parent study, 200 participants; Medical Research Filing No. MR-31-26-073582; ethics approval 2026-178; funding: Bureau-level project 2026150). Why only the acute stage was randomized: DCQD is administered during the acute stage (within 72 h of onset), the stage at which prospective randomization is both feasible and scientifically meaningful. Once patients enter the infection stage (Huang-Qin Decoction combined with Du-Shen Decoction) and recovery stage (Si-Jun-Zi Decoction combined with Ban-Xia-Xie-Xin Decoction), allocation has been determined by the acute-stage randomization and the acute-stage intervention has already been administered; separate prospective trials for these stages would be neither feasible nor scientifically meaningful. No independent protocols exist for the later stages; their data are collected within the parent protocol. Final attribution: Follow-up data from these 60 participants will be fully incorporated into the parent cohort (n = 200) for final analysis. This registration covers the acute-stage randomized comparison of DCQD versus standard Western treatment alone. DCQD composition: Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine.
Interventions
DRUGDa-Cheng-Qi Decoction Plus Standard Western Treatment
Participants in this arm receive standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and circulatory, respiratory, and nutritional support) PLUS Da-Cheng-Qi Decoction, a classical purgative herbal formula comprising Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine. DCQD is administered 100 mL via nasogastric tube twice daily for 7 days during the acute stage.
OTHERStandard Western Treatment
Standard management of severe acute pancreatitis: acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support including circulatory, respiratory, and nutritional support.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were masked to group assignment; the control preparation was presented in identical packaging to mimic the appearance of the study decoction. A dedicated staff member not involved in outcome assessment prepared and coded the study drugs.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Severe acute pancreatitis diagnosed according to the revised Atlanta classification * Age 18-80 years * Disease onset within 72 h * Intra-abdominal hypertension (IAP \>= 12 mmHg) within 24 h of admission * Written informed consent obtained
Exclusion criteria
* Age \<18 or \>80 years * Pregnancy or lactation * Advanced malignancy (pancreatic, hepatobiliary, or gastrointestinal) * Severe chronic organ failure * Autoimmune disease or immunosuppression * Intra-abdominal hemorrhage * Urinary tract infection or prior bladder surgery (precluding bladder manometry) * Allergic constitution or known allergy to study medication * Psychiatric illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intra-abdominal Pressure | From baseline before the first dose through Day 7, assessed every 12 hours after randomization | Intra-abdominal pressure measured by standardized bladder manometry at baseline and every 12 h for 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool Output | Day 1 through Day 7 | Cumulative stool volume per 24-hour interval. |
| Length of Hospital Stay | From randomization to hospital discharge or through study completion, an average of 33 days | Duration of hospitalization from admission to discharge |
| Length of ICU Stay | From randomization to intensive care unit discharge, up to 28 days | Duration of intensive care unit stay. |
| 28-Day Mortality | 28 days | All-cause mortality within 28 days of randomization. |
| Adverse Events | From randomization to day 28 | Incidence and severity of adverse events during treatment and follow-up. |
Countries
China
Contacts
STUDY_CHAIREnqiang Mao, MD, PhD
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed