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Central and Cerebral Circulation in Early Stages After LVAD Implantation

NCT03087669 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-03-22

No results posted yet for this study

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

Interventions

DEVICE

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

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)

DRUG

MAP intervention using Noradrenalin

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

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Sven Erik Ricksten, MD.PhD · Sahlgrenska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03087669 on ClinicalTrials.gov