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Enteral Nutrition in Acute Pancreatitis

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Enteral nutrition
Sponsored by
University Hospital Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Pancreatitis, Acute necrotizing, Enteral nutrition, Fasting, Complications, Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • onset of symptoms consistent with AP within 72 hours before admission to the hospital
  • an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal
  • APACHE II score 6 or more
  • a signed informed consent

Exclusion Criteria:

  • patients < 18 years of age
  • pregnant and breastfeeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Enteral nutrition

    Nil-by-mouth treatment

    Arm Description

    In the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours.

    The nil-by-mouth treatment consists intravenous fluid replacement according to assessed needs via peripheral veins. This will include crystalloid (0.9% saline and 5% glucose), and colloid (10% hydroxyethyl starch and 3.5% plasma expander - haemaccel) solutions.

    Outcomes

    Primary Outcome Measures

    SIRS (Systemic Inflammatory Response Syndrome)

    Secondary Outcome Measures

    All-cause mortality
    Organ failure (cardiovascular, respiratory, renal)
    Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)
    Local septic complications
    Other infections
    Inflammatory response (CRP on the first and third day)
    Length of hospital stay
    Adverse events

    Full Information

    First Posted
    October 16, 2013
    Last Updated
    March 30, 2015
    Sponsor
    University Hospital Rijeka
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01965873
    Brief Title
    Enteral Nutrition in Acute Pancreatitis
    Official Title
    Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Rijeka

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP). The hypothesis: enteral nutrition is no significantly better compared with the nil-by-mouth principle regarding mortality, incidence of local and systemic complications, length of hospital stay, and intensity of the inflammatory response in patients with moderate to severe AP enteral nutrition has the same safety as nil-by-mouth principle in patients with moderate to severe AP
    Detailed Description
    Patients with first attack of AP irrespective of etiology will be enrolled in the study, if they are eligible according to the following criteria: Inclusion criteria: onset of symptoms consistent with AP within 72 hours before admission to the hospital an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal APACHE II score 6 or more a signed informed consent Exclusion criteria: patients < 18 years of age pregnant and breastfeeding women

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pancreatitis
    Keywords
    Pancreatitis, Acute necrotizing, Enteral nutrition, Fasting, Complications, Mortality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    214 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Enteral nutrition
    Arm Type
    Experimental
    Arm Description
    In the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours.
    Arm Title
    Nil-by-mouth treatment
    Arm Type
    No Intervention
    Arm Description
    The nil-by-mouth treatment consists intravenous fluid replacement according to assessed needs via peripheral veins. This will include crystalloid (0.9% saline and 5% glucose), and colloid (10% hydroxyethyl starch and 3.5% plasma expander - haemaccel) solutions.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Enteral nutrition
    Intervention Description
    Same as arm description
    Primary Outcome Measure Information:
    Title
    SIRS (Systemic Inflammatory Response Syndrome)
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    All-cause mortality
    Time Frame
    4 weeks
    Title
    Organ failure (cardiovascular, respiratory, renal)
    Time Frame
    4 weeks
    Title
    Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)
    Time Frame
    4 weeks
    Title
    Local septic complications
    Time Frame
    4 weeks
    Title
    Other infections
    Time Frame
    4 weeks
    Title
    Inflammatory response (CRP on the first and third day)
    Time Frame
    First and third day of admission
    Title
    Length of hospital stay
    Time Frame
    4 weeks
    Title
    Adverse events
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: onset of symptoms consistent with AP within 72 hours before admission to the hospital an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal APACHE II score 6 or more a signed informed consent Exclusion Criteria: patients < 18 years of age pregnant and breastfeeding women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Davor Štimac, MD, PhD
    Organizational Affiliation
    Department of Gastroenterology, University Hospital Rijeka
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27107634
    Citation
    Stimac D, Poropat G, Hauser G, Licul V, Franjic N, Valkovic Zujic P, Milic S. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: A randomized clinical trial. Pancreatology. 2016 Jul-Aug;16(4):523-8. doi: 10.1016/j.pan.2016.04.003. Epub 2016 Apr 13.
    Results Reference
    derived

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    Enteral Nutrition in Acute Pancreatitis

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