<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03001687</url>
  </required_header>
  <id_info>
    <org_study_id>434/24.11.2016</org_study_id>
    <nct_id>NCT03001687</nct_id>
  </id_info>
  <brief_title>Impact of Vitamin D Supplementation on Hepcidin Levels and Transfusion Requirements in Surgical and Septic Patients</brief_title>
  <acronym>DEHEPTRA</acronym>
  <official_title>Impact of Vitamin D Enteral Supplementation on Hepcidin Serum Levels and Transfusion Requirements in Surgical and Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iuliu Hatieganu University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Iuliu Hatieganu University of Medicine and Pharmacy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute inflammation induced by surgery and sepsis is complicated by the development of&#xD;
      iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes&#xD;
      intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin&#xD;
      might be a potential target to reduce transfusion requirements in surgical and sepsis&#xD;
      patients. Vitamin D supplementation might constitute a novel strategy to modulate the&#xD;
      hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that&#xD;
      by using vitamin D supplementation in surgical and septic shock patients, the physicians&#xD;
      could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a&#xD;
      randomised controlled trial to determine the impact of high-dose vitamin D enteral&#xD;
      supplementation on serum hepcidin levels and transfusion requirements after major abdominal&#xD;
      surgery and in septic shock patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient blood management has become an important concept for the perioperative care of the&#xD;
      surgical patients and in septic patients, aiming to improve outcomes. Hepcidin might be a&#xD;
      potential target to reduce transfusion requirements after major abdominal surgery and in&#xD;
      patients with sepsis. Major surgery and sepsis induce complex immune dysregulations,&#xD;
      characterised by a pro-inflammatory state (the postoperative acute-phase reaction). Excess&#xD;
      hepcidin values in acute inflammatory conditions might represent an exaggerated response that&#xD;
      leads to iron-sequestration anemia, a functional iron deficiency anemia. Vitamin D&#xD;
      supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron&#xD;
      axis in surgery and sepsis-induced acute inflammation. Thus, vitamin D might impact hepcidin&#xD;
      values and might reduce transfusion requirements.&#xD;
&#xD;
      I. Inflammation-induced regulation of the hepcidin-ferroportin-iron axis&#xD;
&#xD;
      Surgery and sepsis are associated with iron-restricted anemia. After major abdominal surgery&#xD;
      and sepsis, a prototypical inflammatory syndrome, often complicated by the development of&#xD;
      anemia, appears. Inflammatory cytokines (like interleukin 6) released during acute infection&#xD;
      alter iron metabolism by inducing excess synthesis of hepcidin. Anemia after major abdominal&#xD;
      surgery and sepsis may be the expression of impaired erythropoiesis as a result of hepcidin&#xD;
      up-regulation. Hepcidin plays a role in the development of anemia, together with the&#xD;
      inhibition of erythropoietin production, a decreased lifespan of erythrocytes, and a blunted&#xD;
      erythropoietic response. Functional iron deficiency is increasingly recognised as a cause of&#xD;
      anemia in the general surgical patient and in patients with sepsis.&#xD;
&#xD;
      Iron is a two-faced element. First, iron is essential for living as it is incorporated in the&#xD;
      &quot;breathing&quot; molecule haemoglobin and in the mitochondrial respiratory chain. On the other&#xD;
      hand, iron is detrimental due to the generation of oxidative stress and its availability for&#xD;
      the growing of bacteria. Low serum iron level is considered detrimental as it leads to anemia&#xD;
      and low tissue oxygen delivery. Iron deficiency and anemia are associated with poor outcomes&#xD;
      in surgical and septic patients. Also, transfusion is associated with immune suppression and&#xD;
      other adverse reactions. Thus, other approaches to the correction of anemia are advocated,&#xD;
      even though not yet included in the clinical practice.&#xD;
&#xD;
      Hepcidin is the master regulator of iron metabolism and hence, a modulator of anemia in&#xD;
      states of inflammation. Hepcidin is an acute phase protein synthetised in the liver and which&#xD;
      acts as an hyposideremia inducing hormone. It binds to ferroportin (an iron exporter) and&#xD;
      prevents the release of iron from the cells: prevents the absorption of dietary iron from&#xD;
      enterocytes and prevents iron release from macrophages, where it is stored. Thus, the effect&#xD;
      of hepcidin would be iron sequestration, lowering the serum iron concentrations. The&#xD;
      beneficial result would be a low availability of iron for bacterial growth (thus, a direct&#xD;
      antimicrobial effect) and less oxidative stress. The detrimental result is the limited&#xD;
      possibility for the synthesis of new haemoglobin molecules and the occurrence of anemia. The&#xD;
      up-regulation of hepcidin, as a pro-inflammatory biomarker, characterises both acute and&#xD;
      chronic inflammatory conditions. The induction of hepcidin synthesis may be the cause for the&#xD;
      iron-restricted erythropoiesis in the surgical population and in patients with sepsis. The&#xD;
      induction of hepcidin synthesis may contribute to the development of anemia, which is&#xD;
      detrimental for tissue oxygenation and might increase transfusion requirements and the&#xD;
      aggravation of immune suppression after blood transfusion. In animal models of anemia due to&#xD;
      inflammation, hepcidin knockout mice had milder anemia and faster recovery.&#xD;
&#xD;
      Excess values of the iron regulating hormone hepcidin causes intracellular sequestration of&#xD;
      iron and might decrease the availability of iron for erythropoiesis, leading to the anemia&#xD;
      frequently encountered in inflammatory conditions. Anemia is not only very frequent among&#xD;
      critically ill patients, but is associated with increased transfusion rates and worse&#xD;
      outcomes. Anemia may impair oxygen delivery to peripheral tissues and impose transfusion,&#xD;
      which itself carries the risk of further immune suppression. Recent data has emphasised the&#xD;
      need to restrict transfusions as much as possible, as transfusion is associated with&#xD;
      increased morbidity and mortality. Instead, alternative methods to improve anemia and&#xD;
      ameliorate tissue oxygen delivery might be beneficial.&#xD;
&#xD;
      II. Vitamin D down-regulates hepcidin expression&#xD;
&#xD;
      Vitamin D is a hormone promoting bone health, which also has a wide range of cellular&#xD;
      activities including the differentiation of hematopoietic cells and down-regulation of&#xD;
      inflammatory cytokines. Vitamin D has anti-inflammatory and immune-regulating properties and&#xD;
      the maintenance of adequate vitamin D status may play a role in managing inflammation and&#xD;
      immunity. Vitamin D supplementation in patients with chronic inflammatory conditions like&#xD;
      chronic kidney disease improves the values of circulating markers of inflammation and&#xD;
      immunity. Recently, it has been highlighted that in certain conditions, like chronic kidney&#xD;
      disease, the administration of vitamin D reduces serum hepcidin values and transfusion&#xD;
      requirements.&#xD;
&#xD;
      Up to now, there are no data regarding the possibility that by using vitamin D&#xD;
      supplementation in surgical or septic shock patients, the physicians could target the&#xD;
      hepcidin-ferroportin-iron axis to prevent the occurrence of anemia and, hence, reduce&#xD;
      transfusion requirements. Oral vitamin D supplementation lowers hepcidin values and might&#xD;
      increase erythropoiesis and decrease inflammation.&#xD;
&#xD;
      III. Vitamin D supplementation in the critically ill. Safety profile&#xD;
&#xD;
      The therapeutic potential of vitamin D is a topic of intense interest. A high prevalence of&#xD;
      low vitamin D levels has been confirmed in patients who are critically ill. Vitamin D&#xD;
      deficiency is associated with higher infection rates, 30-day mortality and in-hospital&#xD;
      mortality in adult critically ill patients. During critical illness, vitamin D&#xD;
      supplementation has a favorable safety profile and a possible mechanism of vitamin D&#xD;
      supplementation in inducing bactericidal pleiotropic effects has been suggested. To improve&#xD;
      vitamin D status, high-dose vitamin D is required in the critically ill, as they display a&#xD;
      blunted response to supplementation. Recent evidence suggests that treatment of vitamin-D&#xD;
      deficient critically ill patients may improve outcomes and mortality, possibly through&#xD;
      enhancing innate immunity and the inhibition of proinflammatory cytokines. Further clinical&#xD;
      trials to explore the effects of vitamin D supplementation on the up-regulation process of&#xD;
      proinflammatory cytokines are needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hepcidin concentration (ng/mL)</measure>
    <time_frame>one week after intervention</time_frame>
    <description>Hepcidin serum concentrations measured one week after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Packed red cells</measure>
    <time_frame>two weeks after intervention</time_frame>
    <description>The number of transfused packed red cells in the first two weeks after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Systemic Inflammatory Response Syndrome</condition>
  <condition>Sepsis</condition>
  <condition>Surgical Injuries</condition>
  <arm_group>
    <arm_group_label>vitamin D +</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the &quot;vitamin D&quot; group will receive enteral supplementation with vitamin D, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vitamin D -</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in &quot;vitamin D -&quot; group do not receive enteral supplementation with vitamin D and represent the control group, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>enteral supplementation with vitamin D</intervention_name>
    <description>Patients allocated to the &quot;vitamin D +&quot; group receive enteral supplementation with high-dose vitamin D (250.000UI)</description>
    <arm_group_label>vitamin D +</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood collection 3mL</intervention_name>
    <description>all patients will have hepcidin levels measured in the first 24 hours after admission and one week after</description>
    <arm_group_label>vitamin D +</arm_group_label>
    <arm_group_label>vitamin D -</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sepsis and septic shock patients&#xD;
&#xD;
          -  patients with major abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic inflammatory conditions (chronic kidney disease, hematologic, and&#xD;
             rheumatic/autoimmune disease)&#xD;
&#xD;
          -  morbid obesity (BMI over 40kg/m2)&#xD;
&#xD;
          -  pregnancy and lactation&#xD;
&#xD;
          -  hypercalcemia (total calcium&gt; 10.6mg/dL, serum ionized calcium&gt;5.4mg/dL)&#xD;
&#xD;
          -  tuberculosis, sarcoidosis&#xD;
&#xD;
          -  nephrolithiasis&#xD;
&#xD;
          -  recent history of vitamin D supplementation or erythropoietin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cristina Petrisor, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luminita Goga</last_name>
    <phone>+40-264-597-256</phone>
    <email>contact@umfcluj.ro</email>
  </overall_contact>
  <location>
    <facility>
      <name>Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca</name>
      <address>
        <city>Cluj-napoca</city>
        <state>Cluj</state>
        <zip>400012</zip>
        <country>Romania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cristina Petrisor, MD,PhD,DESA</last_name>
      <phone>+40722262286</phone>
      <email>petrisor.cristina@umfcluj.ro</email>
    </contact>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <reference>
    <citation>Lasocki S, Longrois D, Montravers P, Beaumont C. Hepcidin and anemia of the critically ill patient: bench to bedside. Anesthesiology. 2011 Mar;114(3):688-94. doi: 10.1097/ALN.0b013e3182065c57. No abstract available.</citation>
    <PMID>21258235</PMID>
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  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Iuliu Hatieganu University of Medicine and Pharmacy</investigator_affiliation>
    <investigator_full_name>Cristina Petrisor</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>hepcidin</keyword>
  <keyword>sepsis</keyword>
  <keyword>surgery</keyword>
  <keyword>vitamin D</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Systemic Inflammatory Response Syndrome</mesh_term>
    <mesh_term>Intraoperative Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only on request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03001687
org study id: 434/24.11.2016
nct id: NCT03001687
lead sponsor: 
has dmc: No
Acute inflammation induced by surgery and sepsis is complicated by the development of
      iron-restricted anemia due to the up-regulation of hepcidin. Excess hepcidin causes
      intracellular sequestration of iron, decreasing its availability for erythropoiesis. Hepcidin
      might be a potential target to reduce transfusion requirements in surgical and sepsis
      patients. Vitamin D supplementation might constitute a novel strategy to modulate the
      hepcidin-ferroportin-iron axis. Up to now, there are no data regarding the possibility that
      by using vitamin D supplementation in surgical and septic shock patients, the physicians
      could ameliorate anemia and, hence, reduce transfusion requirements. Aim: to conduct a
      randomised controlled trial to determine the impact of high-dose vitamin D enteral
      supplementation on serum hepcidin levels and transfusion requirements after major abdominal
      surgery and in septic shock patients.
Patient blood management has become an important concept for the perioperative care of the
      surgical patients and in septic patients, aiming to improve outcomes. Hepcidin might be a
      potential target to reduce transfusion requirements after major abdominal surgery and in
      patients with sepsis. Major surgery and sepsis induce complex immune dysregulations,
      characterised by a pro-inflammatory state (the postoperative acute-phase reaction). Excess
      hepcidin values in acute inflammatory conditions might represent an exaggerated response that
      leads to iron-sequestration anemia, a functional iron deficiency anemia. Vitamin D
      supplementation might constitute a novel strategy to modulate the hepcidin-ferroportin-iron
      axis in surgery and sepsis-induced acute inflammation. Thus, vitamin D might impact hepcidin
      values and might reduce transfusion requirements.

      I. Inflammation-induced regulation of the hepcidin-ferroportin-iron axis

      Surgery and sepsis are associated with iron-restricted anemia. After major abdominal surgery
      and sepsis, a prototypical inflammatory syndrome, often complicated by the development of
      anemia, appears. Inflammatory cytokines (like interleukin 6) released during acute infection
      alter iron metabolism by inducing excess synthesis of hepcidin. Anemia after major abdominal
      surgery and sepsis may be the expression of impaired erythropoiesis as a result of hepcidin
      up-regulation. Hepcidin plays a role in the development of anemia, together with the
      inhibition of erythropoietin production, a decreased lifespan of erythrocytes, and a blunted
      erythropoietic response. Functional iron deficiency is increasingly recognised as a cause of
      anemia in the general surgical patient and in patients with sepsis.

      Iron is a two-faced element. First, iron is essential for living as it is incorporated in the
      "breathing" molecule haemoglobin and in the mitochondrial respiratory chain. On the other
      hand, iron is detrimental due to the generation of oxidative stress and its availability for
      the growing of bacteria. Low serum iron level is considered detrimental as it leads to anemia
      and low tissue oxygen delivery. Iron deficiency and anemia are associated with poor outcomes
      in surgical and septic patients. Also, transfusion is associated with immune suppression and
      other adverse reactions. Thus, other approaches to the correction of anemia are advocated,
      even though not yet included in the clinical practice.

      Hepcidin is the master regulator of iron metabolism and hence, a modulator of anemia in
      states of inflammation. Hepcidin is an acute phase protein synthetised in the liver and which
      acts as an hyposideremia inducing hormone. It binds to ferroportin (an iron exporter) and
      prevents the release of iron from the cells: prevents the absorption of dietary iron from
      enterocytes and prevents iron release from macrophages, where it is stored. Thus, the effect
      of hepcidin would be iron sequestration, lowering the serum iron concentrations. The
      beneficial result would be a low availability of iron for bacterial growth (thus, a direct
      antimicrobial effect) and less oxidative stress. The detrimental result is the limited
      possibility for the synthesis of new haemoglobin molecules and the occurrence of anemia. The
      up-regulation of hepcidin, as a pro-inflammatory biomarker, characterises both acute and
      chronic inflammatory conditions. The induction of hepcidin synthesis may be the cause for the
      iron-restricted erythropoiesis in the surgical population and in patients with sepsis. The
      induction of hepcidin synthesis may contribute to the development of anemia, which is
      detrimental for tissue oxygenation and might increase transfusion requirements and the
      aggravation of immune suppression after blood transfusion. In animal models of anemia due to
      inflammation, hepcidin knockout mice had milder anemia and faster recovery.

      Excess values of the iron regulating hormone hepcidin causes intracellular sequestration of
      iron and might decrease the availability of iron for erythropoiesis, leading to the anemia
      frequently encountered in inflammatory conditions. Anemia is not only very frequent among
      critically ill patients, but is associated with increased transfusion rates and worse
      outcomes. Anemia may impair oxygen delivery to peripheral tissues and impose transfusion,
      which itself carries the risk of further immune suppression. Recent data has emphasised the
      need to restrict transfusions as much as possible, as transfusion is associated with
      increased morbidity and mortality. Instead, alternative methods to improve anemia and
      ameliorate tissue oxygen delivery might be beneficial.

      II. Vitamin D down-regulates hepcidin expression

      Vitamin D is a hormone promoting bone health, which also has a wide range of cellular
      activities including the differentiation of hematopoietic cells and down-regulation of
      inflammatory cytokines. Vitamin D has anti-inflammatory and immune-regulating properties and
      the maintenance of adequate vitamin D status may play a role in managing inflammation and
      immunity. Vitamin D supplementation in patients with chronic inflammatory conditions like
      chronic kidney disease improves the values of circulating markers of inflammation and
      immunity. Recently, it has been highlighted that in certain conditions, like chronic kidney
      disease, the administration of vitamin D reduces serum hepcidin values and transfusion
      requirements.

      Up to now, there are no data regarding the possibility that by using vitamin D
      supplementation in surgical or septic shock patients, the physicians could target the
      hepcidin-ferroportin-iron axis to prevent the occurrence of anemia and, hence, reduce
      transfusion requirements. Oral vitamin D supplementation lowers hepcidin values and might
      increase erythropoiesis and decrease inflammation.

      III. Vitamin D supplementation in the critically ill. Safety profile

      The therapeutic potential of vitamin D is a topic of intense interest. A high prevalence of
      low vitamin D levels has been confirmed in patients who are critically ill. Vitamin D
      deficiency is associated with higher infection rates, 30-day mortality and in-hospital
      mortality in adult critically ill patients. During critical illness, vitamin D
      supplementation has a favorable safety profile and a possible mechanism of vitamin D
      supplementation in inducing bactericidal pleiotropic effects has been suggested. To improve
      vitamin D status, high-dose vitamin D is required in the critically ill, as they display a
      blunted response to supplementation. Recent evidence suggests that treatment of vitamin-D
      deficient critically ill patients may improve outcomes and mortality, possibly through
      enhancing innate immunity and the inhibition of proinflammatory cytokines. Further clinical
      trials to explore the effects of vitamin D supplementation on the up-regulation process of
      proinflammatory cytokines are needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Hepcidin concentration (ng/mL)
time frame: one week after intervention
description: Hepcidin serum concentrations measured one week after the intervention
measure: Number of Packed red cells
time frame: two weeks after intervention
description: The number of transfused packed red cells in the first two weeks after the intervention
arm group label: vitamin D +
arm group type: Experimental
description: Patients in the "vitamin D" group will receive enteral supplementation with vitamin D, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement
arm group label: vitamin D -
arm group type: Placebo Comparator
description: Patients in "vitamin D -" group do not receive enteral supplementation with vitamin D and represent the control group, blood collection 3mL is performed in the first 24 hours after admission and one week later for serum hepcidin measurement
intervention type: Dietary Supplement
intervention name: enteral supplementation with vitamin D
description: Patients allocated to the "vitamin D +" group receive enteral supplementation with high-dose vitamin D (250.000UI)
arm group label: vitamin D +
intervention type: Other
intervention name: blood collection 3mL
description: all patients will have hepcidin levels measured in the first 24 hours after admission and one week after
arm group label: vitamin D +
arm group label: vitamin D -
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Cristina Petrisor, MD, PhD
role: Principal Investigator
affiliation: University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca
last name: Luminita Goga
phone: +40-264-597-256
email: contact@umfcluj.ro
facility: 
status: Recruiting
contact: 
country: Romania
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responsible party type: Principal Investigator
investigator affiliation: Iuliu Hatieganu University of Medicine and Pharmacy
investigator full name: Cristina Petrisor
investigator title: Principal Investigator
mesh term: Systemic Inflammatory Response Syndrome
mesh term: Intraoperative Complications
mesh term: Vitamin D
sharing ipd: No
ipd description: Only on request