Condition category
Digestive System
Date applied
01/08/2012
Date assigned
27/09/2012
Last edited
27/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

The Mulartz Henrik Surgical Foundation (Hungary)

Sponsor details

Vasvari P. u. 2.
Gyor
9024
Hungary

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes