Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

University of Auckland, New Zealand

Status: Withdrawn

Conditions: Acute Pancreatitis

Treatments: Procedure: Nasogastric Tube Feeding; Other: Conventional Nutritonal Management

Study type: Interventional

Funder types: Other

Identifiers

NCT01798511

13/NTA/9

Details and patient eligibility

About

Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of AP
• Age 18 years or older
• Written informed consent
• Ongoing need for opiates

Exclusion criteria

• 96 hours after onset of symptoms
• Chronic pancreatitis
• Post-ERCP pancreatitis
• Intraoperative diagnosis
• Pregnancy
• Malignancy
• Received nutrition before randomisation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Nasogastric Tube Feeding

Experimental group

Description:

Patients who are to have NTF will receive enteral nutrition within 6 hours after randomisation via a nasogastric tube placed into the stomach. A commercially available low fat semi-elemental feed (Peptisorb®, Nutricia Clinical NZ) will be used. The caloric target will be 2000 kcal per day. Enteral tube feeding will be commenced at a rate of 30 mL/h and increased gradually until 100 mL/h over 24-48 h.

Treatment:

Procedure: Nasogastric Tube Feeding

Conventional Nutritional Management

Active Comparator group

Description:

Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case enteral tube feeding will be introduced) or the signs of AP mitigate,in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced.

Treatment:

Other: Conventional Nutritonal Management