Intravenous glutamine-dipeptide and early nasojejunal feeding in severe acute pancreatitis

ISRCTN ISRCTN60549685
DOI https://doi.org/10.1186/ISRCTN60549685
Secondary identifying numbers G-2008/12
Submission date
01/08/2012
Registration date
27/09/2012
Last edited
27/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Nora Hajdu
Scientific

The Mulartz Henrik Surgical Foundation
Vasvari P. u. 2.
Gyor
9024
Hungary

Email kajda@freemail.hu

Study information

Study designSingle-center prospective randomized double-blind clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA combination of intravenous glutamine-dipeptide and early nasojejunal nutrition in severe acute pancreatitis: a prospective randomized double-blind clinical trial
Study objectivesIntravenous glutamine may be beneficial with early nasojejunal feeding in prevention of septic complications in severe acute pancreatitis.
Ethics approval(s)Regional Science and Research Ethics Commitee of Petz Aladar Teaching Hospital, 04/09/2008, ref: 76-1-28/2008
Health condition(s) or problem(s) studiedSevere acute pancreatitis
InterventionThe 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 typeSupplement
Primary outcome measure1. Rate of pancreas-specific infectious complications
2. Organ failures
Secondary outcome measures1. Comparison of radiological and surgical interventions
2. Length of hospital stay
3. Mortality rate
Overall study start date04/09/2008
Completion date04/09/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30 patients in each groups
Key inclusion criteria1. Patients admitted with severe acute pancreatitis
2. Glasgow score at least 3 or CRP level over 150 mg/ml
Key exclusion criteria1. 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
Date of first enrolment04/09/2008
Date of final enrolment04/09/2012

Locations

Countries of recruitment

  • Hungary

Study participating centre

The Mulartz Henrik Surgical Foundation
Gyor
9024
Hungary

Sponsor information

The Mulartz Henrik Surgical Foundation (Hungary)
Research organisation

Vasvari P. u. 2.
Gyor
9024
Hungary

Funders

Funder type

Research organisation

The Mulartz Henrik Surgical Foundation (Hungary)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan