Acute Pancreatitis, Systemic Inflammatory Response Syndrome
Conditions
Keywords
Non-steroidal anti-inflammatory drugs, indomethacin
Brief summary
Acute pancreatitis is a common critical disease of the digestive system. Accumulated data showed that overexpression of cyclooxygenase-2 (COX-2) in acute pancreatitis and experimental pancreatitis could be attenuated with COX-2 inhibitors. In recent years, it has been found that timely administration of indomethacin or diclofenac sodium to anus after ERCP can significantly reduce the incidence of AP after ERCP in patients at high risk of AP. The aim of this study was to evaluate the efficacy of rectal indomethacin in reducing the systemic inflammatory response syndrome (SIRS) score in AP patients.
Interventions
DRUGIndometacin
Besides the conventional treatment, indomethacin will be given to the patients in the convention + indomethacin group.
OTHERconventional treatment
All enrolled patients received conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(i) either gender aged 18-70 years; (ii) a confirmed diagnosis of AP; (iii) the time interval from the onset of symptoms to admission was no more than 48 h; (iv) written informed consent was obtained from the patients or their legal representatives.
Exclusion criteria
(i) pregnancy and breast feeding mother; (ii) severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency, cirrhosis, inflammatory bowel diseases, and malignancies; (iii) peptic ulcer; (iv) pancreatitis due to trauma; (v) drug allergy; (vi) drug abuse and psychosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention. | 72 hours after the initial intervention. | The minimum value of SIRS is 0, and the maximum value of SIRS is 4. The higher score means a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the serum levels of C-reactive protein(CRP) | 72 hours after the initial intervention. | The normal range of CRP is 0-10mg/L, and the higher value means a worse outcome. |
| the serum levels of interleukin-6(IL-6) | 72 hours after the initial intervention. | The normal range of IL-6 is 0-7pg/ml, and the higher value means a worse outcome. |
| score of abdominal pain | 72 hours after the initial intervention. | The range of score of abdominal pain is 0-10, and the higher value means a worse outcome. |
Countries
China
Contacts
Primary ContactYuahua Han
Backup ContactGangzhi Zhang
Outcome results
None listed