Endocrine Response of the Organism to Polytrauma
Primary Purpose
Polytrauma
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Vitamin D3 + anabolic substance
No Vitamin D3 + anabolic substance
Sponsored by
About this trial
This is an interventional treatment trial for Polytrauma focused on measuring polytrauma, endocrine response, metabolic response, bone metabolism, anabolic substance, vitamin D
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
Sites / Locations
- University Hospital Ostrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vitamin D3 + anabolic substance
Retrospective analysis
Arm Description
Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance
Retrospectively analyzed patients, no vitamin D3 + anabolic substance administration.
Outcomes
Primary Outcome Measures
Bone metabolism
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 Outcome Measures
Time of healing in patients with multiple fractures
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)
Full Information
NCT ID
NCT03588767
First Posted
June 26, 2018
Last Updated
February 17, 2023
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT03588767
Brief Title
Endocrine Response of the Organism to Polytrauma
Official Title
Endocrine Response of the Organism to Polytrauma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polytrauma
Keywords
polytrauma, endocrine response, metabolic response, bone metabolism, anabolic substance, vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 + anabolic substance
Arm Type
Experimental
Arm Description
Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance
Arm Title
Retrospective analysis
Arm Type
Active Comparator
Arm Description
Retrospectively analyzed patients, no vitamin D3 + anabolic substance administration.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 + anabolic substance
Intervention Description
Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance
Intervention Type
Other
Intervention Name(s)
No Vitamin D3 + anabolic substance
Intervention Description
Retrospectively analyzed group of patients, no Vitamin D3 + anabolic substance administration
Primary Outcome Measure Information:
Title
Bone metabolism
Description
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
Time Frame
39 months
Secondary Outcome Measure Information:
Title
Time of healing in patients with multiple fractures
Description
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)
Time Frame
39 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Different age limits in males and females will be used as eligibility criteria for patients enrolled in the study. Males of 18-60 years of age and females of 18-50 years of age will be eligible for participation in the study. This difference is explained by the different bone metabolism in male and female patients.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renáta Ječmínková, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
708 52
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data my be provided upon request.
Learn more about this trial
Endocrine Response of the Organism to Polytrauma
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