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Central Hemodynamics, Augmentation index and Microcirculation after Phlebotomy

Completed
Conditions
Heamochroomatosis (Iron overlad)
polycythemia (too much red blood cels)
10038158
10019654
Registration Number
NL-OMON38739
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
42
Inclusion Criteria

Without volume replacement:
- Patients aged 18-75 years receiving phlebotomy at regular intervals (for example because of hemochromatosis, porphyria and polycythemia vera)
- Known to tolerate phlebotomy
- Willing to participate
- Able to provide informed consent.
Patients which are known to tolerate phlebotomy without any adverse events are included in the *no-volume replacement group.* Patients who have experienced adverse events after phlebotomy in the past, and are previously assigned to receive volume replacement by their attending physician, are included in the *volume replacement group.* We aim to include the same amount of patients in each group.

Exclusion Criteria

- Pacemaker or ICD device
- Atrial fibrillation
- Mechanical heart valve
- Congestive heart failure (*NYHA III/IV)
- Unable to stand up
- Uncontrolled hypertension (BP>180/110 mmHg)

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Significant difference in aortic augmentation as well as difference in<br /><br>central BP of * 10 mmHg systolic or * 5 mmHg diastolic before and after<br /><br>phlebotomy in supine and standing position with or without counter maneuvers.-<br /><br>- Difference in aortic augmentation of * 4% as well as difference in central BP<br /><br>of * 10 mmHg systolic or * 5 mmHg diastolic after phlebotomy in patients with<br /><br>or without saline infusion (viscosity changed/unchanged). </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To assess the effects of phlebotomy on cardiac output and peripheral resistance<br /><br>while supine and after standing<br /><br>To assess the effects of phlebotomy on forward and backward waves in supine<br /><br>position and after standing<br /><br>To assess the effects of phlebotomy with saline repletion on cardiac output and<br /><br>peripheral resistance while supine and after standing<br /><br>To assess the effects of phlebotomy with saline repletion on forward and<br /><br>backward waves in supine position and after standing</p><br>
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