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Trial record 2 of 45 for:    senescent

VItamin D Metabolism in SEnescent Cardiac Surgery Patients (VISE)

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ClinicalTrials.gov Identifier: NCT01378221
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia

Tracking Information
First Submitted Date June 20, 2011
First Posted Date June 22, 2011
Results First Submitted Date December 11, 2013
Results First Posted Date January 30, 2014
Last Update Posted Date January 30, 2014
Study Start Date September 2009
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2013)
Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients [ Time Frame: change from baseline within 1 month after cardiac surgery ]
Original Primary Outcome Measures
 (submitted: June 20, 2011)
Peri- and postoperative time course of circulating 1,25-dihydroxyvitamin D in the first postoperative month in cardiac surgery patients [ Time Frame: change from baseline within 1 month after cardiac surgery ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 20, 2011)
  • peri- and postoperative time course of proinflammatory cytokines and cardiac surgery patients [ Time Frame: change from baseline within one month after cardiac surgery ]
  • peri- and postoperative time course of immunological paramters in cardiac surgery patients patients [ Time Frame: change from baseline within 1 month after cardiac surgery ]
  • peri- and postoperative time course of serum minerals in cardiac surgery patients [ Time Frame: change from baseline within 1 month after cardiac surgery ]
  • baseline serum levels of calciotropic hormones according to age [ Time Frame: day before cardiac surgery ]
  • postoperative outcome [ Time Frame: Participants will be followed for the duration of in-hospital stay, an expected average of 8-10 days ]
    composite endpoint of in-hospital mortality and postopeartive complications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title VItamin D Metabolism in SEnescent Cardiac Surgery Patients
Official Title Vitamin D Metabolism in Senescent Cardiac Surgery Patients
Brief Summary Advanced age is associated with an increase in postoperative morbidity and mortality in cardiac surgery patients. In detail, compared with younger patients those aged 75 years and older have significantly higher rates of in-hospital mortality, cerebrovascular events, pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system. Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term mortality in patients with a high risk for cardiovascular disease. Mild renal impairment, insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly individuals. The present study aimed to investigate whether cardiac surgery exerts age-dependent effects on calciotropic hormones, components of the immune system, and inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels are lower in patients <= 75 years of age compared to younger patients, (ii) cardiac surgery results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger cardiac surgery patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population elective cardiac surgery patients receiving isolated coronary artery bypass grafting or combined coronary artery bypass grafting and heart valve surgery
Condition
  • Coronary Artery Bypass Grafting
  • Heart Valve Surgery
Intervention Not Provided
Study Groups/Cohorts
  • Group 1
    cardiac surgery patients age 65 years and less
  • Group 2
    cardiac surgery patients aged 75 years and over
Publications * Börgermann J, Lazouski K, Kuhn J, Dreier J, Schmidt M, Gilis-Januszewski T, Knabbe C, Gummert JF, Zittermann A. 1,25-Dihydroxyvitamin D fluctuations in cardiac surgery are related to age and clinical outcome*. Crit Care Med. 2012 Jul;40(7):2073-81. doi: 10.1097/CCM.0b013e31824e8c42.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 11, 2013)
75
Original Actual Enrollment
 (submitted: June 20, 2011)
74
Actual Study Completion Date May 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age: <= 65 years and >= 75 years
  • first elective cardiac surgery (bypass or combined bypass and heart valve surgery)
  • written informed consent

Exclusion Criteria:

  • emergency cardiac intervention
  • primary hyperparathyreoidism
  • primary and secondary hypoparathyreoidism
  • daily vitamin D supplementation > 10 micrograms
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01378221
Other Study ID Numbers 005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Heart and Diabetes Center North-Rhine Westfalia
Study Sponsor Heart and Diabetes Center North-Rhine Westfalia
Collaborators Not Provided
Investigators
Principal Investigator: Jochen Börgermann, MD Heart Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany
PRS Account Heart and Diabetes Center North-Rhine Westfalia
Verification Date December 2013