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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN86556841

Enrollment

Registered

2005-06-15

Start date

2005-08-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative immune hypoparesis in children undergoing major surgery Surgery

Interventions

Perioperative intravenous glutamine infusion versus isonitrogenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
HLA DR expression by monocytes, and exvivo production of tumour necrosis factor (TNF) alpha following lipopolysaccharide stimulation	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026