sternotomy healing MedDRA version: 19.0 Level: PT Classification code 10051501 Term: Sternotomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: VIGANTOL
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: COLECALCIFEROL
Other descriptive name: cholecalciferol
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Nemocnice Na Homolce
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The CT is designed for men and women aged between 18 and 95 meeting these requirements: 1. undegoing of cadiothoracic surgery procedure with sternotomy; 2. initial levels of kalcium, phosphate, alcalic phosphatase within normal limits; 3. sufficient patient capability to understand the conditions of clinical study; 4. patients speaking Czech or Slovak language; 5. patients with initial level of calcidiol under 75 nmol/l ; 6. written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 550
Exclusion criteria
Exclusion criteria: Those who can not attend this CT are patients: 1) with reported hyperparathyreosis; 2) treated or supplemented by vitamin D or its derivatives (alfacalcifediol, calcitriol, paricalcitol...) including ergocalciferol, if they have been treated by this medication regularly 3 months ago before the entrance to the clinical trial; 3) undergoing repeated sternotomy; 4) with chronic kidney disease associated with osteodystrophy (hyperphosphatemia, hypocalcemia); 5) with severe hepatic failure (Child Pugh Score B or C); 6) with reported metabolic skeletal disease; 7) with oncological disease associated with primary or secondary skeleton damage; 8) with reported immune deficiency; 9) with short bowel syndrome or other malabsorption syndrome, that limits lipophilic vitamin gut absorption; 10) with cardioactive glycoside and/or thiazide diuretic long term treatment that can not be switched to alternative medication during hospitalization for cardiothoracic surgery procedure; 11) before planned radiotherapy targeting skeleton; 12) with reported alergy to any of CT medication; 13) with teriparatide (or another parathormone derivative) long term treatment; 14) with bile acid sequestrant long term treatment that can not be replaced by another hypolipidemic treatment; 15) with corticosteroids or another immune supresive agents long term treatment; 16) with another clinical situation, when main investigator will deem the risk for patient to take part the CT 17) prisoners and detaineed persons 18) pregnant, brest feeding women or women planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to study the effect of placebo controlled vitamin D3 supplementation on sternotomy healing complications (early and late) in cardiac surgery patients with vitamin D hypovitaminosis when calcidiol blood concentration is monitored before and after study;Secondary Objective: There are five secondary objectives: 1) to evaluate the difference in number of ventilatory and ICU days after cardiac surgery between placebo and treated group; 2) to evaluate the difference in number of hospital readmissions due to sternotomy healing complications between placebo and treated group; 3) to evaluate the difference in number of corticosteroid treatment days due to pericardial or pleural effusions between placebo and treated group, if this treatment is used; 4) to monitor the weight gain or weight loss of the patients in placebo and treated group; 5) to monitor the difference in serious adverse effects potentially associated with clinical trial medication (hypercalcemia and hypercalciuria) occurence during the clinical trial in placebo and treated group ;Primary end point(s): 1) sternal crepitation after 6 weeks following sternotomy – YES/NO; 2) full sternal resurgence after 6 months following sternotomy –YES/NO; 3) scar and soft tissues status in area of sternotomy after 6 weeks and 6 months following sternotomy – healed YES/NO 4) scar and soft tissues status in area of peripheral arterial or venous conduit collection after 6 weeks and 6 months following coronary arteries revascularisation – healed YES/NO (pacients undergoing coronary arteries revascularisation ONLY); ;Timepoint(s) of evaluation of this end point: 1) sternal crepitation after 6 weeks following sternotomy – YES/NO; 2) full sternal resurgence after 6 months following sternotomy –YES/NO; 3) scar and soft tissues status in area of sternotomy after 6 weeks and 6 months following sternotomy – healed YES/NO 4) scar and soft tissues status in area of peripheral arterial or venous conduit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) number or hospital readmisions for sternotomy dehiscence within the CT duration; 2) number of ICU spent days with mechanical ventilation; 3) number of ICU days; 4) number of days spent by treatment of pericardial and pleural effusions 5) weight gain/loss ;Timepoint(s) of evaluation of this end point: All the secondary endpoints will be evaluated at the end of CT. | — |
Countries
Czech Republic
Contacts
Public ContactDalibor Cerný
Nemocnice Na Homolce
Outcome results
None listed