Influence of low-dose i.v. growth hormone treatment together with glutamine supplementation in late-phase critically ill patient after multiple injury. A pilot study. - AGHATA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004727-36-CZ

Enrollment

Registered

2005-01-10

Start date

2005-02-10

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Prolonged phase of critical illness after severe multiple trauma

Interventions

Trade Name: Norditropin Simplexx Product Name: Norditropin Simplexx Product Code: 56/223/01-C Pharmaceutical Form: Solution for injection INN or Proposed INN: Somatotropinum humanum (Human growth horm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Multiple trauma patients admitted to Dept. of Anaesthesia and Criticla Care Medicine of Kralovske Vinohrady University Hospital, Prague. Age 18-60 years, both sexes, on the 4th day after injury expected to stay at least a week in the ICU. Written informed consent (given by the closest relative in inconcious subjects). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes mellitus or other known endocrinopathy, gravidity, known allergy to growth hormone), head injury involving hypothalamo-pituitary region, treatment of immune suppresants of high-dose corticoids.

Design outcomes

Primary

Measure	Time frame
Main Objective: To prove that low-dose i.v. growth hormone given together with glutamine supplementation to late-phase critically ill multiple trauma patients has potent protein-anabolic properties and does not influence immune status and metabolic parametres.;Secondary Objective: To assess behaviour of IGF-axis in the control group. To bring an indirect evidence that glutamine-depletion-induced immune suppresion was responsible for adverse outcomes of patient treated with GH alone (i.e. without glutamine supplementation). To assess the influence of growth hormone treatment on apoptosis of B- and T-lymphocytes, prevalence of infection, the lenght of dependency on artificial ventilation as well as the influence of GH treatment on the tolerance of artificial nutrition and overall morbidity and mortality after 3-month follow up.;Primary end point(s): Nitrogen balance Immune status checked by lymphocyte proliferation test, apoptotic lymphocyte count and respiratory burst of neutrophiles Insulin resistance measured by insulin requirements to maintain euglycaemia and by hyperinsulinemic euglycemic clamp method	—

Measure

Time frame

Main Objective: To prove that low-dose i.v. growth hormone given together with glutamine supplementation to late-phase critically ill multiple trauma patients has potent protein-anabolic properties and does not influence immune status and metabolic parametres.;Secondary Objective: To assess behaviour of IGF-axis in the control group. To bring an indirect evidence that glutamine-depletion-induced immune suppresion was responsible for adverse outcomes of patient treated with GH alone (i.e. without glutamine supplementation). To assess the influence of growth hormone treatment on apoptosis of B- and T-lymphocytes, prevalence of infection, the lenght of dependency on artificial ventilation as well as the influence of GH treatment on the tolerance of artificial nutrition and overall morbidity and mortality after 3-month follow up.;Primary end point(s): Nitrogen balance Immune status checked by lymphocyte proliferation test, apoptotic lymphocyte count and respiratory burst of neutrophiles Insulin resistance measured by insulin requirements to maintain euglycaemia and by hyperinsulinemic euglycemic clamp method

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Countries

Czech Republic

Outcome results

None listed

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