Clinical trial NCT03588767: Endocrine Response of the Organism to Polytrauma
Official title: Endocrine Response of the Organism to Polytrauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polytrauma
Keywords: polytrauma
endocrine response
metabolic response
bone metabolism
anabolic substance
vitamin D
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with polytrauma will be administered vitamin D3 + anabolic substance. Group of an identical size of patients who were treated in the past without administration of vitamin D3 and anabolic substance will be analyzed retrospectively.
Primary purpose: TREATMENT

Brief summary: The serious injury causes a complex acute response of the organism to the injury in affected patients, which is manifested in the neuroendocrine, immune and metabolic areas, with an often persisting catabolic state, with a subsequent negative impact upon bone metabolism.

By a timely administration of the D3 vitamin and an anabolic, we attempt to achieve an earlier activation of the anabolic phase of patient resuscitation after serious trauma regarding the monitoring of laboratory values of bone metabolism.

Detailed description: Polytrauma and serious complex injuries evoke a vast acute response of the organism to the injury in patients with serious trauma, not only in the form of trauma-haemorrhagic instability; the metabolic response of the organism to trauma also changes, these changes are manifested with activation of integration systems, in the areas of hemocoagulation, as well as changes in the form of changes in the endocrine and immunology systems. The extent of these changes always depends upon the extent and intensity of the mechanism of injury, together with the extent and type of impairment of individual organ systems in the polytraumatized patient.

1. primarily, due to the extent of the anatomic injury caused by trauma
2. due to the need to mobilize the reserves in order to repair the impaired tissues
3. due to the need to activate the main integration systems in the following areas: endocrine, neurological and immunology

Immediately after the injury, the organism reacts to the load with acute phase response, which is characterized with stimulation of the hypothalamus-hypophysis-adrenal glands axis, with activation of the sympathoadrenal system, furthermore with stimulation of synthesis of proteins of the acute phase, activation of the immune system (B-cells and T-cells), activation of neutrophils, fibroblasts, and endothelial cells. At the same time, significant catabolism of proteins occurs, together with changes of levels of various hormones. This pertains primarily to an early decrease of levels of anabolic-acting testosterone, dihydrotestosterone, and free testosterone, and also the total and ionized calcium, high levels of the parathyroid hormone, interleukin-6, cortisol and changes in thyroidal hormones, etc.

At present, substation therapy with an early administration of a substitution dose of vitamin D3 after determination of its level is recommended to treat this endocrine reaction, together with anabolic substances, such as nandrolone decanoate (Deca-Durabolin) already on the first day, while respecting the contraindications, with the aim to reverse the catabolic phase of the polytrauma into the anabolic phase, which, apart from other indicators, influences the parameters of bone metabolism, which may be monitored in the laboratory.

The aim of the study is to verify, whether the administration of substitution vitamin D3 does and anabolic-acting Deca-Durabolin substance (concomitant) from the beginning of the treatment leads to

1. elimination of bone reabsorption
2. earlier initiation of the bone remodeling phase in patients affected with a polytrauma, in comparison with a group of similarly traumatized patients from a retrospective file, who did not receive this treatment.

A group of 30 polytraumatized patients with administration of vitamin D3 and Deca-Durabolin anabolic substance will be retrospectively compared to a group of patients treated at the Department of Trauma Surgery, University Hospital Ostrava with ISS\>31 in the past years.

Administered substances

1. Vitamin D3 - Bon 200 000 I.U. i.m. on the first day of trauma, and 3 weeks after trauma, following the verification of 25/OH/ vitamin D value, further substitution of vitamin D in the form of Vigantol 5000I.U. drops administered per os once a week for the period of 6 weeks; the total period of treatment lasting 9 weeks
2. Anabolic substance - Deca-Durabolin 50mg i.m. on the first day of trauma, a repeated dose of Deca-Durabolin 50mg i.m. 1amp. every 3 weeks; the total period of treatment lasting 9 weeks

Parameters of the bone metabolism and endocrine response will be monitored (telopeptide CTx- beta mass, bone alkaline phosphatase, osteocalcin, type-I procollagen propeptide, bone fraction of alkaline phosphatase, total and ionized calcium, S+U, phosphorus S+U, parathyroid hormone, 25-OH vitamin D, Cortisol S+U , testosterone, dihydrotestosterone, free testosterone, T3, fT4, 17 beta-estradiol/, interleukin 6. These parameters were monitored on the 1st, 7th, 14th, 28th and 70th day.

The results will be analyzed with statistical methods for the purpose of further assessment and evaluation.

Eligibility criteria: Inclusion Criteria:

* serious polytrauma with ISS\>31b
* females, 18-50 years of age
* males, 18-60 years of age
* signed informed consent with participation in the study

Exclusion Criteria:

* infaust craniocerebral injury
* gravidity
* lactation
* prostate cancer

Primary outcomes:
measure: Bone metabolism
timeFrame: 39 months
Secondary outcomes:
measure: Time of healing in patients with multiple fractures
timeFrame: 39 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Renáta Ječmínková, MD
role: PRINCIPAL_INVESTIGATOR
References: