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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Meropenem

Intervention Type DRUG

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

Interventions

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Meropenem

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No