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Central Hemodynamics, Augmentation index and Microcirculation after Phlebotomy


- candidate number14978
- NTR NumberNTR4038
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2013
- Secondary IDs44193 ABR
- Public TitleCentral Hemodynamics, Augmentation index and Microcirculation after Phlebotomy
- Scientific TitleCentral Hemodynamics, Augmentation index and Microcirculation after Phlebotomy
- ACRONYMCHAMP study
- hypothesisRecently it has been demonstrated that upon standing wave reflection and central blood pressure (BP) decrease despite an increase in systemic vascular resistance. The decrease in central aortic augmentation and central BP can be attenuated by unilateral leg compression. This suggests that aortic augmentation (AIx) and central BP are sensitive to alterations in venous return. Our principal aim is to assess whether changes in volume status affect aortic augmentation (AIx) and central BP in patients receiving regular phlebotomy while supine and after standing. Because changes in blood viscosity may influence AIx, BP and cardiac output, the current study also aims to assess the difference of BP and AIx in patient who receive volume replacement after.
- Healt Condition(s) or Problem(s) studiedMicrocirculation, Plasma viscosity, Augmentation index, Phlebotomy, Central blood pressure
- Inclusion criteria- Patients aged 18-75 years receiving phlebotomy at regular intervals (for example because of hemochromatosis or polycythemia vera) ;
- Willing to participate ;
- Able to provide informed consent.
- 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 11-jun-2013
- planned closingdate31-dec-2013
- Target number of participants42
- InterventionsPhlebotomy with or without volume replacement. Each patient serves as his or her own control. The hemodynamic measurements from before the phlebotomy (500ml) are compared to the hemodynamic measurements after phlebotomy.
- Primary outcomeThe principal endpoint is defined as the difference in AIx (≥4%) before and after phlebotomy while standing.
- Secondary outcomeDifference in central BP before and after phlebotomy while standing
• Differences in AIx and central BP before and after phlebotomy while supine
• Differences in AIX and central BP following the effects of counter manoeuvres (leg crossing and thigh compression) before and after phlebotomy while standing
• Differences in stroke volume, heart rate and systemic vascular resistance before and after phlebotomy while supine and after standing
• Differences in forward and backward wave analysis before and after phlebotomy while supine and after standing
• Differences in baroreflex sensitivity before and after phlebotomy while supine and after standing
• Differences in AIx and central BP after phlebotomy and after compensatory saline infusion while supine and after standing
• Differences in stroke volume, heart rate and systemic vascular resistance after phlebotomy and after compensatory saline infusion while supine and after standing
• Differences in forward and backward wave analysis after phlebotomy and after compensatory saline infusion while supine and after standing
• Differences in forward and backward wave analysis after phlebotomy and after compensatory saline infusion while supine and after standing
• Differences in AIX and central BP following the effects of counter manoeuvres (leg crossing and thigh compression) minutes after phlebotomy and after compensatory saline infusion
• Difference in microcirculation before and after phlebotomy with or without volume replacement.
- TimepointsA total of six measurement moments are done with the arteriograph: in supine position (t=10), in standing position (t=15) and with countermanouevres (t=20) before the intervention (phlebotomy). After the phlebotomy the same measurement regime is done (t=35, t=40 and t=45, respectively). At the same time a continuous measurement is done with the nexfin (before and after intervention). Objectified parameters are: central BP, AIx, PWV, stroke volume, heart rate, systemic vascular resistance, cardiac output, pulse pressure, baroreflex and MAP. At t=0 and again at t=55 microcirculation is objectified with a SDF-camera. Blood samples (Hb, ht and plasma viscocity) will be collected before (t=25) and after phlebotomy (t=50).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES N.V. Hoeven, van der
- CONTACT for SCIENTIFIC QUERIES B.J. Born, van den
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryOur principal aim is to assess the effects of phlebotomy on aortic augmentation (AIx) and central BP in supine position and after standing, second, to assess the effects of counter manoeuvres (leg crossing and thigh compression) on aortic augmentation (AIx) and central BP before and after phlebotomy while standing and third, the difference between viscosity change and volume depletion on aortic augmentation (AIx) and central BP.The burden of this study consists of one visit, with a duration of approximately one hour. The patients will be assigned a group (volume replacement or no volume replacement) depending on the regular receiving care; when a patient experienced negative effects after phlebotomy (such as dizziness, light headedness, weakness and/or collapse), the patient is assigned to receive volume replacement by their attending physician. The techniques used are the Nexfin, the Arteriograph and the MicroScan Video Microscope which will measure central BP, MAP, AIx, stroke volume, heart rate, systemic vascular resistance, forward and backward waves, cardiac output, pulse pressure, baroreflex and objectify microcirculation in supine and standing position with and without counter manoeuvres before and after phlebotomy. Furthermore a short questionnaire will be taken to assess record patients’ age, gender, medical history, demographic variables, medication use and co-morbidity. Also length, weight and waist circumference will be measured. Finally a blood sample will be taken before and after the phlebotomy for hemoglobin, plasma viscosity and hematocrit.
- Main changes (audit trail)
- RECORD11-jun-2013 - 30-jun-2013


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