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Completed

NCT Number: NCT03588767

Endocrine Response of the Organism to Polytrauma

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

About this study

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.

  • primarily, due to the extent of the anatomic injury caused by trauma
  • due to the need to mobilize the reserves in order to repair the impaired tissues
  • 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

  • elimination of bone reabsorption
  • 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

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3 + anabolic substance

Drug

Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance

No Vitamin D3 + anabolic substance

Other

Retrospectively analyzed group of patients, no Vitamin D3 + anabolic substance administration

Primary outcomes

  1. Bone metabolism

    Time frame: 39 months

    Measurement of the P1NP parameter of bone metabolism (earlier bone remodelling): increase of the P1NP parameter over 170% on the 70th day after injury - yes/no

Secondary outcomes

  1. Time of healing in patients with multiple fractures

    Time frame: 39 months

    The time of healing will be assessed in patients with multiple fractures - measured in the number of months until complete healing is confirmed with radio diagnostic examination (X-ray)

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 17, 2018
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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