Endocrine Response of the Organism to Polytrauma
Condition: Polytrauma
MeSH terms: Multiple Trauma
Study type: Interventional

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.
    

Intervention name(s): Vitamin D3 + anabolic substance; No Vitamin D3 + anabolic substance
Intervention type(s): Drug; Other
Intervention description(s): Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance; Retrospectively analyzed group of patients, no Vitamin D3 + anabolic substance administration
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Anabolic Androgenic Steroids; Testosterone Congeners
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polytrauma; endocrine response; metabolic response; bone metabolism; anabolic substance; vitamin D