NCT03454802

Brief Summary

The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre. The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Simultaneously blood pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the ICU. Analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

February 10, 2018

Last Update Submit

September 18, 2021

Conditions

Cardiovascular Insufficiency

Outcome Measures

Primary Outcomes (9)

  • Changes in cardiovascular variables I

    stroke volume, SV (mL)

    10 minutes

  • Changes in cardiovascular variables II

    pulse rate, PR (min\^-1)

    10 minutes

  • Changes in cardiovascular variables III

    blood pressure, BP (mmHg)

    10 minutes

  • Changes in cardiovascular variables IV

    pulse oximetric saturation, SpO2 (%)

    10 minutes

  • Changes in HRV frequency domain variables V

    Heart rate variability, HRV, variables in frequency domain (low frequency, LF, 0.04-0.15 Hz, high frequency, HF, 0.15-0.4 Hz)

    10 minutes

  • Changes in HRV frequency domain variables VI

    HRV absolute power (ms\^2, natural logarithm transformed values of absolute powers of very low frequency, VLF, LF, and HF bands)

    10 minutes

  • Changes in HRV frequency domain variables VII

    HRV relative power (absolute power/total power)

    10 minutes

  • Changes in HRV frequency domain variables VIII

    HRV normalized power (%, normalized units, n.u.)

    10 minutes

  • Changes in HRV frequency domain variables IX

    HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.

    10 minutes

Study Arms (3)

Normal subjects

ACTIVE COMPARATOR

Normal subjects 'Passive Leg Raising'

Diagnostic Test: Passive Leg Raising

ICU patients

ACTIVE COMPARATOR

ICU patients 'Passive Leg Raising'

Diagnostic Test: Passive Leg Raising

Cardiac Outpatients

ACTIVE COMPARATOR

Cardiac Outpatients 'Passive Leg Raising'

Diagnostic Test: Passive Leg Raising

Interventions

Passive Leg RaisingDIAGNOSTIC_TEST

See above

Cardiac OutpatientsICU patientsNormal subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting after written and oral information

You may not qualify if:

  • Contraindications to PLR: intracranial or abdominal hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regionshospitalet Silkeborg

Silkeborg, Central Jutland, 8600, Denmark

Location

Related Publications (1)

  • Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.

    PMID: 16540963RESULT

Study Officials

  • Peter Toft, MD

    Head of Centre of Planned Surgery, Silkeborg Regional Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant, MD, PhD

Study Record Dates

First Submitted

February 10, 2018

First Posted

March 6, 2018

Study Start

September 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)