Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 47 for:    senescent

VItamin D Metabolism in SEnescent Cardiac Surgery Patients (VISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Coronary Artery Bypass Grafting
Heart Valve Surgery
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description cardiac surgery patients age 65 years and less cardiac surgery patients aged 75 years and over
Period Title: Overall Study
Started 36 39
Completed 29 30
Not Completed 7 9
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description cardiac surgery patients age 65 years and less cardiac surgery patients aged 75 years and over Total of all reporting groups
Overall Number of Baseline Participants 29 30 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 29 participants 30 participants 59 participants
58.8  (5.92) 77.0  (4.38) 68.05  (5.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Female
2
   6.9%
9
  30.0%
11
  18.6%
Male
27
  93.1%
21
  70.0%
48
  81.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 29 participants 30 participants 59 participants
29 30 59
1.Primary Outcome
Title Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients
Hide Description [Not Specified]
Time Frame change from baseline within 1 month after cardiac surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
cardiac surgery patients age 65 years and less
cardiac surgery patients aged 75 years and over
Overall Number of Participants Analyzed 29 30
Mean (Standard Error)
Unit of Measure: percentage
13  (1.1) 4.2  (0.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description cardiac surgery patients age 65 years and less cardiac surgery patients aged 75 years and over
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Armin Zittermann
Organization: Heart and Diabetes Center North Rhine-Westphalia, Germany
Phone: +49 5731 97 ext 1912
EMail: azittermann@hdz-nrw.de
Layout table for additonal information
Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01378221    
Other Study ID Numbers: 005
First Submitted: June 20, 2011
First Posted: June 22, 2011
Results First Submitted: December 11, 2013
Results First Posted: January 30, 2014
Last Update Posted: January 30, 2014