Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics
Primary Purpose
Acute Pancreatitis
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Meropenem
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring acute pancreatitis
Eligibility 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
Sites / Locations
- Benazir Bhutto Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
Antibiotics
Arm Description
This arm was not given any prophylactic antibiotics. Patients were managed in the surgical ward by post graduate residents under the supervision of consultants
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
Outcomes
Primary Outcome Measures
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.
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.)
Secondary Outcome Measures
Full Information
NCT ID
NCT02212392
First Posted
August 5, 2014
Last Updated
August 6, 2014
Sponsor
Benazir Bhutto Hospital, Rawalpindi
1. Study Identification
Unique Protocol Identification Number
NCT02212392
Brief Title
Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics
Official Title
COMPARING THE OUTCOME IN PATIENTS OF ACUTE PANCREATITIS, WITH AND WITHOUT PROPHYLACTIC ANTIBIOTICS.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benazir Bhutto Hospital, Rawalpindi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
acute pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
This arm was not given any prophylactic antibiotics. Patients were managed in the surgical ward by post graduate residents under the supervision of consultants
Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Meropenem
Intervention Description
inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days
Primary Outcome Measure Information:
Title
Extrapancreatic infections
Description
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.
Time Frame
14 days
Title
Duration of hospital stay
Description
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.)
Time Frame
average 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fazal H Shah, MBBS, FCPS I
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sohail Rashid, MBBS, FCPS
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bilal Altaf, MBBS, FCPS I
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Muhammad Hanif, MBBS, FCPS
Organizational Affiliation
Benazir Bhutto Hospital, Rawalpindi
Official's Role
Study Chair
Facility Information:
Facility Name
Benazir Bhutto Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19082671
Citation
Garcia-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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
18374839
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
19952294
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.
Results Reference
background
PubMed Identifier
16771960
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. doi: 10.1111/j.1572-0241.2006.00567.x.
Results Reference
background
PubMed Identifier
19220676
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.
Results Reference
background
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Comparing the Outcome in Patients of Acute Pancreatitis, With and Without Prophylactic Antibiotics
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