VISE: VItamin D Metabolism in SEnescent Cardiac Surgery Patients

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01378221
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Duration (Months): 19.9
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Grafting; Heart Valve Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Vitamin D Metabolism in Senescent Cardiac Surgery Patients
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Group 1 cardiac surgery patients age 65 years and less
Group 2 cardiac surgery patients aged 75 years and over

Outcome Measures

Primary Outcome Measures

1. Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients [change from baseline within 1 month after cardiac surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center North Rhine-Westphalia	Bad Oeynhausen	North Rhine-Westphalia	Germany	32545

Sponsors and Collaborators

• Heart and Diabetes Center North-Rhine Westfalia

Investigators

• Principal Investigator: Jochen Börgermann, MD, Heart Center NRW, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
• ClinicalTrials.gov Identifier: NCT01378221
• Other Study ID Numbers: 005
• First Posted: Jun 22, 2011
• Last Update Posted: Jan 30, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Heart and Diabetes Center North-Rhine Westfalia: vitamin D; cardiac surgery; inflammation; immune system; age

Study Results

Participant Flow

Arm/Group Title	Group 1	Group 2
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

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Total
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 Participants	29	30	59
Age (years) [Mean (Standard Deviation) ]
Age	58.8 (5.92)	77.0 (4.38)	68.05 (5.14)
Sex: Female, Male (Count of Participants)
Female	2 6.9%	9 30%	11 18.6%
Male	27 93.1%	21 70%	48 81.4%
Region of Enrollment (participants) [Number]
Germany	29 100%	30 100%	59 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2
Arm/Group Description	cardiac surgery patients age 65 years and less	cardiac surgery patients aged 75 years and over
Measure Participants	29	30
Mean (Standard Error) [percentage]	13 (1.1)	4.2 (0.2)

Adverse Events

Arm/Group Title	Group 1		Group 2
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.