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
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
Scientific
The Mulartz Henrik Surgical Foundation
Vasvari P. u. 2.
Gyor
9024
Hungary
| kajda@freemail.hu |
Study information
| Study design | Single-center prospective randomized double-blind clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A combination of intravenous glutamine-dipeptide and early nasojejunal nutrition in severe acute pancreatitis: a prospective randomized double-blind clinical trial |
| Study objectives | Intravenous 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) studied | 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 |
| Primary outcome measure | 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 study start date | 04/09/2008 |
| Completion date | 04/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 patients in each groups |
| Key inclusion criteria | 1. Patients admitted with severe acute pancreatitis 2. Glasgow score at least 3 or CRP level over 150 mg/ml |
| Key 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 |
| Date of first enrolment | 04/09/2008 |
| Date of final enrolment | 04/09/2012 |
Locations
Countries of recruitment
- Hungary
Study participating centre
9024
Hungary
Sponsor information
Research organisation
Vasvari P. u. 2.
Gyor
9024
Hungary
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
