To investigate whether a very early start of EN (< 24 hrs after admission), as compared to selective delayed EN (> 72 hrs), will lead to a lower rate of infectious complications and mortality in patients with predicted severe AP.
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the fraction of patients with an infectious
complication or mortality during hospital stay (composite endpoint).
Re-admission within 10 days after discharge is considered as one hospital
admission.
Secondary outcome
Secondary endpoints occurring during hospital admission include:
• Individual components of the primary endpoint
• Urinary tract infection (dysuria with bacteruria >10.000 CFU/mL)
• Nutrition related complications: diarrhea, aspiration pneumonia,
pneumothorax due to
central TPN catheter placement
• Need for conversion from EN to TPN
• Days until intake of solid food
• Use of antibiotics
• Pain relapse
• CRP and leukocytes as measures of systemic inflammation
• Length of hospital stay
• Need for ICU admission
• New onset organ failure (onset, extent and duration, see definitions section)
• Length of ICU stay
• Need for percutaneous drainage
• Need for surgical or endoscopical necrosectomy
• Gastrointestinal permeability measured with the PEG test
• Hand grip strength measured once per week
• Quality of life and total direct and indirect costs
• Proportion of daily nutritional target achieved at 1 week after admission.
• Number of patients without the need for tube feeding.
• Cross-over between both study arms.
Background summary
In patients with predicted severe acute pancreatitis, enteral nutrition (EN)
via a feeding tube reduces the risk of infectious complications and mortality
compared to total parenteral nutrition. It has been suggested that very early
EN* (i.e. < 24 hours after admission) reduces morbidity and mortality as
compared to the current practice of starting EN after 3-4 days when it becomes
clear that the patient will be not able to eat for several days.
Study objective
To investigate whether a very early start of EN (< 24 hrs after admission), as
compared to selective delayed EN (> 72 hrs), will lead to a lower rate of
infectious complications and mortality in patients with predicted severe AP.
Study design
A randomised controlled parallel group superiority multicenter trial. Patients
will be randomly allocated to A) EN < 24 hours after hospital admission or B)
EN after 72 hours of admission.
Intervention
Nasojejunal EN < 24 hours after admission
Study burden and risks
In the early enteral nutrition arm patients will recieve a nasojejunal feeding
tube within 24 hours of hospital admission. Enteral nutrition will be started
and increased to full nutrition in 48-72 hrs. If a patient will be able to eat
after a few days, the feeding tube will be removed. In the late nutrition arm
patients wil be evaluated after 72 hrs if they are able to eat or not. If not
they will recieve a nasogastric feeding tube.
This study will imply no extra risks for the patients involved. A nasojeunal
feeding tube is safe and most patients with acute pancreatitis recieve a
nasojejunal feeding tube. Blood test are performed in accordance to normal
testing days.
Geert Grooteplein zuid 10
6500 HB Nijmegen
NL
Geert Grooteplein zuid 10
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Acute pancreatitis: upper abdominal pain and serum lipase and/ or amylase levels 3 times the upper level of normal
Age 18 years or above
Written informed consent
Exclusion criteria
History of acute or chronic pancreatitis
Admitted to hospital > 24 hours (either for acute pancreatitis or for other conditions)
Symptoms > 96 hours (4 days)
Acute pancreatitis due to malignancy
Diagnosis of acute pancreatitis during operation for acute abdomen
Post ERCP pancreatitis
Already on artificial nutrition (enteral or parenteral)
Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN18170985 |
| CCMO | NL20057.041.07 |