Perioperative glutamine administration: a potential therapy for preventing post-operative immune hypo-responsiveness

ISRCTN	ISRCTN86556841
DOI	https://doi.org/10.1186/ISRCTN86556841
Secondary identifying numbers	04 SG 25

Submission date: 27/04/2005
Registration date: 15/06/2005
Last edited: 25/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Agostino Pierro
Scientific

Surgery Unit
30 Guilford Street
London
WC1N 3EH
United Kingdom

Phone	+44 (0)207 905 2641
Email	pierro.sec@ich.ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Perioperative glutamine administration: a potential therapy for preventing post-operative immune hypo-responsiveness
Study objectives	Intravenous administration of glutamine before, during and after major operations counteracts the immune hypo-responsiveness that follows major surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Post-operative immune hypoparesis in children undergoing major surgery
Intervention	Perioperative intravenous glutamine infusion versus isonitrogenous infusion
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Glutamine
Primary outcome measure	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 study start date	01/08/2005
Completion date	31/08/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	96
Key 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
Key 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.
Date of first enrolment	01/08/2005
Date of final enrolment	31/08/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Surgery Unit

London
WC1N 3EH
United Kingdom

Sponsor information

The Institute of Child Health (UK)
Research organisation

30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)207 905 2179
Email	e.pendleton@ich.ucl.ac.uk
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Sports Aiding Medical Research for Kids (SPARKS) (UK)

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

Editorial Notes

25/05/2016: No publications found, verifying study status with principal investigator