Condition category
Surgery
Date applied
27/04/2005
Date assigned
15/06/2005
Last edited
25/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes

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