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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

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 8, 2014
Last Update Posted Date August 8, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • 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.
  • 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.)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics
Official Title  ICMJE COMPARING THE OUTCOME IN PATIENTS OF ACUTE PANCREATITIS, WITH AND WITHOUT PROPHYLACTIC ANTIBIOTICS.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Acute Pancreatitis
Intervention  ICMJE Drug: Meropenem
inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days
Study Arms  ICMJE
  • 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
    Intervention: Drug: Meropenem
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2014)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02212392
Other Study ID Numbers  ICMJE ap3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.Fazal hussain Shah, Benazir Bhutto Hospital, Rawalpindi
Study Sponsor  ICMJE Benazir Bhutto Hospital, Rawalpindi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Benazir Bhutto Hospital, Rawalpindi
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP