Plain English Summary
Background and study aims
We are carrying out a study on patients with severe acute pancreatitis, which is a life-threatening disease where the pancreas becomes inflamed. Parenteral nutrition, also known as intravenous feeding, is a method of getting nutrients into the body through the veins. Other studies have shown the benefits of intravenous glutamine with total parenteral nutrition in severe acute pancreatitis. The aim of this study is to determine the effects of intravenous glutamine in severe acute pancreatitis patients who are being fed through a nasojejunal feeding tube (a tube which goes from the nose to the small intestine).
Who can participate?
Patients aged over 18 with severe acute pancreatitis.
What does the study involve?
Participants are randomly allocated into two groups. In the glutamine group, participants receive a glutamine drip for 7 days. In the control group, participants get a drip of other amino acids of the same quantity for the same period. Both groups are otherwise treated in the same way, including early nasojejunal feeding. During their hospital stay, we record the frequency of infectious complications, organ failures, the rate of operations and radiological interventions, length of hospital stay and death rate.
What are the possible benefits and risks of participating?
Glutamine drips are frequently used in intensive care, but are not so widespread in surgery, probably because other combined amino acid solutions are well-known and cheaper. It has no side effects as it is an amino acid normally found in the human body.
Where is the study run from?
Petz Aladar County Teaching Hospital, Györ, Hungary.
When is the study starting and how long is it expected to run for?
September 2008 to September 2012.
Who is funding the study?
Mulartz Henrik Surgical Foundation (Hungary).
Who is the main contact?
Nora Hajdu
kajda@freemail.hu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nora Hajdu
ORCID ID
Contact details
The Mulartz Henrik Surgical Foundation
Vasvari P. u. 2.
Gyor
9024
Hungary
-
kajda@freemail.hu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G-2008/12
Study information
Scientific title
A combination of intravenous glutamine-dipeptide and early nasojejunal nutrition in severe acute pancreatitis: a prospective randomized double-blind clinical trial
Acronym
Study hypothesis
Intravenous glutamine may be beneficial with early nasojejunal feeding in prevention of septic complications in severe acute pancreatitis.
Ethics approval
Regional Science and Research Ethics Commitee of Petz Aladar Teaching Hospital, 04/09/2008, ref: 76-1-28/2008
Study design
Single-center prospective randomized double-blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Severe acute pancreatitis
Intervention
The trial will involve about 60patients, admitted to the surgical department of Petz Aladar County Teaching Hospital, Gyor, Hungary. Participants will recieve the same treatment according to local guidelines, including early nasojejunal nutrition and radiological and surgical interventions, if neccessary, exept for the supplementation of amino acids. Glutamine group will get glutamine, while control group will get a combination of other amino acids usually used in clinical practice as an intravenous supplementation. Participation will start on admission and end at dismissal from hospital.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
1. Rate of pancreas-specific infectious complications
2. Organ failures
Secondary outcome measures
1. Comparison of radiological and surgical interventions
2. Length of hospital stay
3. Mortality rate
Overall trial start date
04/09/2008
Overall trial end date
04/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients admitted with severe acute pancreatitis
2. Glasgow score at least 3 or CRP level over 150 mg/ml
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 patients in each groups
Participant exclusion criteria
1. Age under 18 years
2. Pregnancy
3. Patients with complaints starting before the last 48 hours of admission
4. Death within 48 hours of admission
Recruitment start date
04/09/2008
Recruitment end date
04/09/2012
Locations
Countries of recruitment
Hungary
Trial participating centre
The Mulartz Henrik Surgical Foundation
Gyor
9024
Hungary
Funders
Funder type
Research organisation
Funder name
The Mulartz Henrik Surgical Foundation (Hungary)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary