Central and Cerebral Circulation in Early Stages After LVAD Implantation

NCT03087669 | Unknown

• 1 other identifier: ECOH 3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in early stages after surgical implantation. Within the first 2 days of postoperative ICU care, 20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable blood pressure. A second intervention will be mean arterial blood pressure (MAP) adjustments to 4 preset levels (60-70-80 and 90 mmHg) with a constant preset LVAD flow. The two manipulations; 1) Constant MAP with variation of LVAD flow and 2) Constant LVAD flow with variation of MAP, will be monitored by Central hemodynamic parameters, echocardiographic parameters and cerebral blood flow velocity (CBFV) parameters. The purpose of the trial is to find the optimal combination of LVAD pump flow, mean arterial pressure and right heart ventricle function for each patient. And at the same time describe the effect of flow and pressure variations on CBFV.

Conditions

Heart Failure, Left-Sided; Heart Failure, Right-Sided

Keywords

Left Ventricular Assist Device; Hemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

• Changes PCWP/CVP ratio

  The change in PCWP (mmHg)/CVP (mmHg) ratio at different levels of LVAD flow as a marker for the optimal balance between LVAD flow and RV function

  Change from baseline at different settings of LVAD RPM within 10 minutes for each level

Secondary Outcomes (4)

• CO

  Change from baseline at different settings of LVAD RPM within 10 minutes for each level

• LVAD Velocity Time Integral

  Change from baseline at different settings of LVAD RPM within 10 minutes for each level

• Right Ventricle Outflow Tract (RVOT) Velocity Time Integral (VTI)

  Change from baseline at different settings of LVAD RPM within 10 minutes for each level

• CBFV

  Change from baseline at different settings of LVAD RPM within 10 minutes for each level

Other Outcomes (5)

• Changes PCWP/CVP ratio at different MAP

  Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level

• LVAD VTI at different MAP

  Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level

• CO at different MAP

  Change from baseline at different settings of MAP with a fixed LVAD RPM setting within 10 minutes for each level

Study Arms (1)

Observation of hemodynamic parameters

EXPERIMENTAL

LVAD flow velocity setting-Rounds Per Minute(RPM) intervention: Change of LVAD RPM while observing Central hemodynamic, echocardiographic and CBFV effects. MAP intervention: Stepwise Change of MAP from 60-70-80 to 90 mmHg with a fixed set of LVAD RPM. After a 5 minute steady state for each level of MAP, the observations of central hemodynamics, echocardiographic measures and CBFV measurements will be repeated.

Device: LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®; Drug: MAP intervention using Noradrenalin

Interventions

LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III® DEVICE

Increase in LVAD RPM setting induces an actual increase in LVAD outflow to the patient.This gives the patient an increased systemic Cardiac Output(CO)

Also known as: RPM setting

Observation of hemodynamic parameters

MAP intervention using Noradrenalin DRUG

At a fixed RPM rate for the LVAD the Mean Arterial Pressure (MAP) is increased to preset levels of 60-70-80-90 mmHG using Noradrenalin

Also known as: MAP setting

Observation of hemodynamic parameters

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving LVAD of the type HeartMate3® at Sahlgrenska University hospital

You may not qualify if:

• Perioperative need for an RVAD first 3 days postoperatively after an LVAD implantation

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital. Department of Cardiothoracic Anaesthesia & Intensive Care

Gothenburg, 41345, Sweden

RECRUITING

Related Publications (3)

• Uriel N, Adatya S, Maly J, Kruse E, Rodgers D, Heatley G, Herman A, Sood P, Berliner D, Bauersachs J, Haverich A, Zelizko M, Schmitto JD, Netuka I. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular assist device (HeartMate 3). J Heart Lung Transplant. 2017 Jan;36(1):28-35. doi: 10.1016/j.healun.2016.07.008. Epub 2016 Jul 17.

  PMID: 27773456 RESULT

• Uriel N, Sayer G, Addetia K, Fedson S, Kim GH, Rodgers D, Kruse E, Collins K, Adatya S, Sarswat N, Jorde UP, Juricek C, Ota T, Jeevanandam V, Burkhoff D, Lang RM. Hemodynamic Ramp Tests in Patients With Left Ventricular Assist Devices. JACC Heart Fail. 2016 Mar;4(3):208-17. doi: 10.1016/j.jchf.2015.10.001. Epub 2015 Dec 30.

  PMID: 26746378 RESULT

• Ono M, Joshi B, Brady K, Easley RB, Kibler K, Conte J, Shah A, Russell SD, Hogue CW. Cerebral blood flow autoregulation is preserved after continuous-flow left ventricular assist device implantation. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1022-8. doi: 10.1053/j.jvca.2012.07.014.

  PMID: 23122299 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sven Erik Ricksten, MD.PhD

  Sahlgrenska University Hospital

  STUDY DIRECTOR

Central Study Contacts

Bengt Redfors, MD.PhD

CONTACT

0046313427445; bengt.redfors@vgregion.se

Bjorn Reinsfelt, MD.PhD

CONTACT

0046313428183; bjorn.reinsfelt@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Cardiac Anesthesia. Consultant. PhD

Model Details: 1. LVAD will have a setting of 4800 rounds per minute (RPM). Hemodynamic, echocardiographic and cerebral blood flow measurements will be performed: CO, PCWP, CVP, PAP, MAP, Peripheral and central hemoglobine oxygen saturation (SaO2 and SvO2), Heart Rate (HR), RV outflow tract Velocity Time Integral (RVOT VTI), RV and LV diameter, VTI of LVAD outflow. CBFV of right and left medial cerebral artery (RMCA and LMCA) 2. The above mentioned measurements will be repeated with LVAD settings of 5200 RPM, 5600 RPM, and 6000 RPM. 3. With the LVAD fixed to an optimized setting detected by the previous interventions, the blood pressure will be adjusted to MAP 60 mmHg. The above mentioned measurements will be repeated. 4. Using Noradrenaline the MAP will be adjusted to 70mmHg, 80 mmHg and 90 mmHg. At steady state for each level of MAP with a fixed LVAD flow, all the above mentioned measurements will be repeatedly performed.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 22, 2017
• Study Start: February 16, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)