Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics

Acute Pancreatitis Clinical Trial

Official title:

COMPARING THE OUTCOME IN PATIENTS OF ACUTE PANCREATITIS, WITH AND WITHOUT PROPHYLACTIC ANTIBIOTICS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212392
• Other study ID #: ap3
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 5, 2014
• Last updated: August 6, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Benazir Bhutto Hospital, Rawalpindi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The use of prophylactic antibiotics is beneficial in reducing the extrapancreatic infections and shorter hospital stay in patients of acute pancreatitis as compared to controls.

Description:

Acute pancreatitis (AP) is an acute inflammatory condition of the pancreas that may extend to local and distant extra pancreatic tissues. AP is broadly classified as mild or severe. Most cases of AP are mild with excellent recovery. However 15% to 20% are severe. Bacterial infections play a vital in the course of the disease. Patients with AP are prone to develop extrapancreatic infections like urinary, respiratory and systemic infections. These infections may result in a prolonged hospitalization, systemic inflammatory response syndrome (SIRS), multi-organ system failure and death. The most common causes are gallstones and alcohol intake. AP is managed by intravenous fluids, analgesia and nothing by mouth. However treatment of severe pancreatitis can be challenging, particularly if multiple organ systems are involved or if there are local complications. In severe acute pancreatitis, as pancreatic enzymes and inflammatory mediators damage the blood vessels and leads to extravasation of fluid in to third space. This fluid extravasation leads to local pancreatic necrosis and end-organ failure. Assessment of severity begins in the emergency room or on admission. Signs of SIRS (high or low core body temperature, tachycardia, tachypnea, low or high peripheral white blood cell count) or organ failure (e.g. elevated serum creatinine) are present on admission in 21% of patients with acute pancreatitis. CT should be considered about 3 days after the onset of symptoms rather than immediately upon admission. Eighty per cent of cases of AP are interstitial and mild; the remaining 20% are necrotizing and severe.

The role of prophylactic antibiotics in acute pancreatitis is controversial .A study published in American Journal of Gastroenterology shows results favouring use of antibiotics in acute pancreatitis. This study shows significant reduction in the length of hospitalization in patients who were given prophylactic antibiotics.

Other Internationally conducted studies suggests that there is no or insignificant role of antibiotics for mild acute pancreatitis and role of prophylactic antibiotics in sever acute pancreatitis for better clinical outcome is controversial to say the least.

Rationale of this study was to emphasize that prophylactic antibiotics in patients with acute pancreatitis can improve patient's out come in terms of shorter hospital stay, and reduced number of extrapancreatic infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients between 18 to 70 years of age with diagnosis of acute pancreatitis both mild and sever necrotizing pancreatitis.

• Patients who present within 48 hours of onset of symptoms.

Exclusion Criteria:

• Patients who present after 48 hours of onset of symptoms.

• Patients already taking antibiotics.

• Patients who are immune compromised

• Patients with debilitating illness i.e. tuberculosis, chronic liver disease.

• Patients with trauma, and multiple visceral injuries

• Patients with diagnosed malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Drug:
• Meropenem
inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days

Locations

Country	Name	City	State
Pakistan	Benazir Bhutto Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Benazir Bhutto Hospital, Rawalpindi

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

Bhopal FG, Azhar F, Mahmood S, Iqbal M. Acute pancreatitis; management, morbidity and mortality experience in a surgical unit. Professional Med J 2011;18: 001-007

Cullimore J, Cotter L, Gonzalez A. Antibiotics in acute necrotising pancreatitis. Lancet. 2008 Mar 29;371(9618):1072; author reply 1072. doi: 10.1016/S0140-6736(08)60483-3. — View Citation

García-Barrasa A, Borobia FG, Pallares R, Jorba R, Poves I, Busquets J, Fabregat J. A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotizing pancreatitis. J Gastrointest Surg. 2009 Apr;13(4):768-74. doi: 10.1007/s11605-008-0773-7. Epub 2008 Dec 11. — View Citation

Manes G, Uomo I, Menchise A, Rabitti PG, Ferrara EC, Uomo G. Timing of antibiotic prophylaxis in acute pancreatitis: a controlled randomized study with meropenem. Am J Gastroenterol. 2006 Jun;101(6):1348-53. — View Citation

Stevens T, Parsi MA, Walsh RM. Acute pancreatitis: problems in adherence to guidelines. Cleve Clin J Med. 2009 Dec;76(12):697-704. doi: 10.3949/ccjm.76a.09060. Review. — View Citation

Xue P, Deng LH, Zhang ZD, Yang XN, Wan MH, Song B, Xia Q. Effect of antibiotic prophylaxis on acute necrotizing pancreatitis: results of a randomized controlled trial. J Gastroenterol Hepatol. 2009 May;24(5):736-42. doi: 10.1111/j.1440-1746.2008.05758.x. Epub 2009 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extrapancreatic infections	it includes infections other than pancreas.It includes the bronchopulmonary infections and the urinary tract infection. Cultures of blood ,urine and sputum was performed in patients who develop fever ?380C and high peripheral white blood count (leucocytosis =10,000/mm3) on blood complete picture. The cultures isolated the organism responsible for the infection.	14 days	No
Primary	Duration of hospital stay	It will be measured in terms of mean number of days (i.e. from the day of admission in surgical ward to the day of discharge.)	average 2 weeks.	No