NCT01965873

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2007

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

5.1 years

First QC Date

October 16, 2013

Last Update Submit

March 30, 2015

Conditions

Acute Pancreatitis

Keywords

Pancreatitis, Acute necrotizingEnteral nutritionFastingComplicationsMortality

Outcome Measures

Primary Outcomes (1)

  • SIRS (Systemic Inflammatory Response Syndrome)

    4 weeks

Secondary Outcomes (8)

  • All-cause mortality

    4 weeks

  • Organ failure (cardiovascular, respiratory, renal)

    4 weeks

  • Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)

    4 weeks

  • Local septic complications

    4 weeks

  • Other infections

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Enteral nutrition

EXPERIMENTAL

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.

Dietary Supplement: Enteral nutrition

Nil-by-mouth treatment

NO INTERVENTION

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.

Interventions

Enteral nutritionDIETARY_SUPPLEMENT

Same as arm description

Enteral nutrition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27107634DERIVED

MeSH Terms

Conditions

PancreatitisPancreatitis, Acute NecrotizingFasting

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Davor Štimac, MD, PhD

    Department of Gastroenterology, University Hospital Rijeka

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 18, 2013

Study Start

May 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 3, 2015

Record last verified: 2015-03