Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03588767 |
| Other study ID # |
OCP-UP-TRAUMA |
| Secondary ID |
RVO-FNO/2017 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 31, 2017 |
| Est. completion date |
January 31, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
University Hospital Ostrava |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
