Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis

NCT05637281 | Unknown

• 1 other identifier: IR2022467
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis; Systemic Inflammatory Response Syndrome

Keywords

Non-steroidal anti-inflammatory drugs; indomethacin

Outcome Measures

Primary Outcomes (1)

• Systemic inflammatory response syndrome(SIRS) score at 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.

  72 hours after the initial intervention.

Secondary Outcomes (3)

• the serum levels of C-reactive protein(CRP)

  72 hours after the initial intervention.

• the serum levels of interleukin-6(IL-6)

  72 hours after the initial intervention.

• score of abdominal pain

  72 hours after the initial intervention.

Study Arms (2)

convention

PLACEBO COMPARATOR

patients in convention arm receive 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.

Other: conventional treatment

convention + indometacin

EXPERIMENTAL

Besides the conventional treatment,patients in convention + indometacin arm receive 50-mg indomethacin suppositories at intervals of 12 hours for a total of 6 doses.

Drug: Indometacin; Other: conventional treatment

Interventions

Indometacin DRUG

Besides the conventional treatment, indomethacin will be given to the patients in the convention + indomethacin group.

Also known as: convention + indometacin

convention + indometacin

conventional treatment OTHER

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.

Also known as: convention

convention; convention + indometacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310005, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Systemic Inflammatory Response Syndrome

Interventions

Indomethacin; Congresses as Topic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Organizations; Health Care Economics and Organizations

Central Study Contacts

Yuahua Han

CONTACT

+86 0571 89713734; hanyaohua@zju.edu.cn

Gangzhi Zhang

CONTACT

+8613588153610; arbend@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 5, 2022
• Study Start: December 11, 2022
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: February 17, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)