Central Hemodynamics, Augmentation index and Microcirculation after Phlebotomy

Central Hemodynamics, Augmentation index and Microcirculation after Phlebotomy - CHAMP study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38739

Enrollment

Registered

2013-06-05

Start date

2013-07-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heamochroomatosis (Iron overlad) polycythemia (too much red blood cels)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
- Significant difference in aortic augmentation as well as difference in central BP of * 10 mmHg systolic or * 5 mmHg diastolic before and after phlebotomy in supine and standing position with or without counter maneuvers.- - Difference in aortic augmentation of * 4% as well as difference in central BP of * 10 mmHg systolic or * 5 mmHg diastolic after phlebotomy in patients with or without saline infusion (viscosity changed/unchanged).	—

Measure

Time frame

- Significant difference in aortic augmentation as well as difference in central BP of * 10 mmHg systolic or * 5 mmHg diastolic before and after phlebotomy in supine and standing position with or without counter maneuvers.- - Difference in aortic augmentation of * 4% as well as difference in central BP of * 10 mmHg systolic or * 5 mmHg diastolic after phlebotomy in patients with or without saline infusion (viscosity changed/unchanged).

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Secondary

Measure	Time frame
To assess the effects of phlebotomy on cardiac output and peripheral resistance while supine and after standing To assess the effects of phlebotomy on forward and backward waves in supine position and after standing To assess the effects of phlebotomy with saline repletion on cardiac output and peripheral resistance while supine and after standing To assess the effects of phlebotomy with saline repletion on forward and backward waves in supine position and after standing	—

Measure

Time frame

To assess the effects of phlebotomy on cardiac output and peripheral resistance while supine and after standing To assess the effects of phlebotomy on forward and backward waves in supine position and after standing To assess the effects of phlebotomy with saline repletion on cardiac output and peripheral resistance while supine and after standing To assess the effects of phlebotomy with saline repletion on forward and backward waves in supine position and after standing

—

Countries

Netherlands

Outcome results