Perioperative glutamine administration: a potential therapy for preventing post-operative immune hypo-responsiveness
| ISRCTN | ISRCTN86556841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86556841 |
| Protocol serial number | 04 SG 25 |
| Sponsor | The Institute of Child Health (UK) |
| Funder | Sports Aiding Medical Research for Kids (SPARKS) (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Surgery Unit
30 Guilford Street
London
WC1N 3EH
United Kingdom
| Phone | +44 (0)207 905 2641 |
|---|---|
| pierro.sec@ich.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glutamine |
| Primary outcome measure(s) |
HLA DR expression by monocytes, and exvivo production of tumour necrosis factor (TNF) alpha following lipopolysaccharide stimulation |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
WC1N 3EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/05/2016: No publications found, verifying study status with principal investigator