Trial Outcomes & Findings for VItamin D Metabolism in SEnescent Cardiac Surgery Patients (NCT NCT01378221)

NCT ID: NCT01378221

Last Updated: 2014-01-30

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 75 participants
• Primary outcome timeframe: change from baseline within 1 month after cardiac surgery
• Results posted on: 2014-01-30

Participant Flow

Participant milestones

Measure	Group 1 cardiac surgery patients age 65 years and less	Group 2 cardiac surgery patients aged 75 years and over
Overall Study STARTED	36	39
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VItamin D Metabolism in SEnescent Cardiac Surgery Patients

Baseline characteristics by cohort

Measure	Group 1 n=29 Participants cardiac surgery patients age 65 years and less	Group 2 n=30 Participants cardiac surgery patients aged 75 years and over	Total n=59 Participants Total of all reporting groups
Age, Continuous Age	58.8 years STANDARD_DEVIATION 5.92 • n=5 Participants	77.0 years STANDARD_DEVIATION 4.38 • n=7 Participants	68.05 years STANDARD_DEVIATION 5.14 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Germany	29 participants n=5 Participants	30 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline within 1 month after cardiac surgery

Outcome measures

Measure	Group 1 n=29 Participants cardiac surgery patients age 65 years and less	Group 2 n=30 Participants cardiac surgery patients aged 75 years and over
Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients	13 percentage Standard Error 1.1	4.2 percentage Standard Error 0.2

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Armin Zittermann

Heart and Diabetes Center North Rhine-Westphalia, Germany

Phone: +49 5731 97

Email: azittermann@hdz-nrw.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place