Contact information
Type
Scientific
Primary contact
Prof Agostino Pierro
ORCID ID
Contact details
Surgery Unit
30 Guilford Street
London
WC1N 3EH
United Kingdom
+44 (0)207 905 2641
pierro.sec@ich.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04 SG 25
Study information
Scientific title
Perioperative glutamine administration: a potential therapy for preventing post-operative immune hypo-responsiveness
Acronym
Study hypothesis
Intravenous administration of glutamine before, during and after major operations counteracts the immune hypo-responsiveness that follows major surgery.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Post-operative immune hypoparesis in children undergoing major surgery
Intervention
Perioperative intravenous glutamine infusion versus isonitrogenous infusion
Intervention type
Drug
Phase
Not Specified
Drug names
Glutamine
Primary outcome measures
HLA DR expression by monocytes, and exvivo production of tumour necrosis factor (TNF) alpha following lipopolysaccharide stimulation
Secondary outcome measures
Since glutamine has been shown to influence phagocytic activity we will measure postoperative changes in ß2 integrin expression and activation, internalization and killing of bacteria and respiratory burst, and circulating pro- and anti-inflammatory cytokines. The endocrine/metabolic response to surgery will be assessed by measuring plasma insulin, cortisol, catecholamines, glucose, lactate and free-radical production (malondialdehyde, nitrate/nitrite). In addition the following clinical variables will be recorded: operative complications (e.g. bleeding, intestinal perforation); early postoperative complications (e.g. wound infection, abscess formation, leakage of intestinal anastomosis, evidence of systemic inflammatory response syndrome [SIRS], positive blood culture, bronchopneumonia, urinary tract infection); duration of mechanical ventilation; length of stay in intensive care unit; duration of inotropic requirement; time to full enteral feeding and duration of hospital stay.
Overall trial start date
01/08/2005
Overall trial end date
31/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
96 Children undergoing major surgery at Great Ormond Street Hospital, London. Patients included will be minimised into the following groups of operations
thoracotomy for oesophageal or lung surgery: Nissen fundoplication; laparotomy for intestinal obstruction; colectomy
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
96
Participant exclusion criteria
Patients with pre-existing infection, multi-organ dysfunction syndrome, congenital immune deficiency and congenital or acquired severe liver dysfunction (Child's C) will be excluded.
Recruitment start date
01/08/2005
Recruitment end date
31/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Surgery Unit
London
WC1N 3EH
United Kingdom
Sponsor information
Organisation
The Institute of Child Health (UK)
Sponsor details
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)207 905 2179
e.pendleton@ich.ucl.ac.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Sports Aiding Medical Research for Kids (SPARKS) (UK)
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