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

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ClinicalTrials.gov Identifier: NCT02212392
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Meropenem Phase 1 Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: COMPARING THE OUTCOME IN PATIENTS OF ACUTE PANCREATITIS, WITH AND WITHOUT PROPHYLACTIC ANTIBIOTICS.
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Meropenem

Arm Intervention/treatment
No Intervention: control
This arm was not given any prophylactic antibiotics. Patients were managed in the surgical ward by post graduate residents under the supervision of consultants
Experimental: Antibiotics
this arm was given IV antibiotics, prophylactically, right from the day of admission. They were given intravenous broad spectrum (MEROPENEM) twice daily at 12 hours interval for 7-10 days
Drug: Meropenem
inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days




Primary Outcome Measures :
  1. Extrapancreatic infections [ Time Frame: 14 days ]
    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.

  2. Duration of hospital stay [ Time Frame: average 2 weeks. ]
    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.)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212392


Locations
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Pakistan
Benazir Bhutto Hospital
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Benazir Bhutto Hospital, Rawalpindi
Investigators
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Principal Investigator: Fazal H Shah, MBBS, FCPS I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Sohail Rashid, MBBS, FCPS Benazir Bhutto Hospital, Rawalpindi
Study Chair: Bilal Altaf, MBBS, FCPS I Benazir Bhutto Hospital, Rawalpindi
Study Chair: Muhammad Hanif, MBBS, FCPS Benazir Bhutto Hospital, Rawalpindi

Publications:
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Responsible Party: Dr.Fazal hussain Shah, Resident General surgery, Benazir Bhutto Hospital, Rawalpindi
ClinicalTrials.gov Identifier: NCT02212392     History of Changes
Other Study ID Numbers: ap3
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi:
acute pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anti-Bacterial Agents
Meropenem
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents