NCT01930669

Brief Summary

The purpose of this study is to measure the dysfunction of the autonomic nervous system in modulating the heart rate variability and baroreflex control in critically ill.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1.1 years

First QC Date

August 14, 2013

Last Update Submit

November 3, 2014

Conditions

Autonomic Nervous System Dysfunction in Critically Ill

Keywords

Heart Rate VariabilityMultiple Organ Dysfunction SyndromeCritically Ill

Outcome Measures

Primary Outcomes (1)

  • Incidence of autonomic nervous system dysfunction in critical ill patients

    failure to change significantly HRV and baroreflex variables in response to MTILT.

    from day 1 to day 28

Secondary Outcomes (4)

  • to measure the occurrence of ANS failure in subgroups

    from day 1 to day 28

  • Length of stay in ICU and in Hospital

    8 months

  • mortality

    8 months

  • days free from mechanical ventilation

    28 days

Other Outcomes (1)

  • to define ANS dysfunction and failure in response to MTILT

    28 days

Study Arms (1)

All patients

OTHER

To measure the autonomic nervous system activity elicited by a gravitational sympathetic stimulus in critically ill

Other: Gravitational sympathetic stimulus

Interventions

Gravitational sympathetic stimulusOTHER

Autonomic nervous system (ANS) activity is assessed by means of HRV, SAP variability and baroreflex control analysis daily from day 1 to discharge from ICU or day 28. Analysis is performed (i)at rest in supine position with bed at zero degrees of inclination (ii) during modified tilt (MTILT) and (iii) recovery from MTILT in supine position at zero degrees. In a subgroup of patients motor sympathetic nervous activity (MSNA) is recorded at day 1,2 and 7. MTILT consists in elevating head and trunk of patients at 60 degrees and lowering legs at 15 degree with a standard critical care bed. MSNA is recorded from the external peroneal nerve with microneurographic technique.

All patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted in ICU with
  • age between 18 and 75 years
  • expected length of stay in ICU \>24 hours
  • sinus rhythm on ECG
  • ectopic heart beats \<5% of all heart beats
  • no contraindications of any kind to head-up 60 degrees position

You may not qualify if:

  • age \<18 and \>75 years
  • elective postoperative patients
  • non sinusal rhythm of ECG
  • ectopic heart beats \>5% of all heart beats
  • spinal or head injury
  • suspected or documented intracranial hypertension
  • contraindications of any kind to head up 60 degrees position

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda Ospedaliera "Luigi Sacco" - Polo Universitario - University of Milan

Milan, 20157, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Related Publications (9)

  • Mazzeo AT, La Monaca E, Di Leo R, Vita G, Santamaria LB. Heart rate variability: a diagnostic and prognostic tool in anesthesia and intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):797-811. doi: 10.1111/j.1399-6576.2011.02466.x. Epub 2011 Jun 9.

    PMID: 21658013BACKGROUND

  • Morris JA Jr, Norris PR, Waitman LR, Ozdas A, Guillamondegui OD, Jenkins JM. Adrenal insufficiency, heart rate variability, and complex biologic systems: a study of 1,871 critically ill trauma patients. J Am Coll Surg. 2007 May;204(5):885-92; discussion 892-3. doi: 10.1016/j.jamcollsurg.2007.01.019. Epub 2007 Mar 23.

    PMID: 17481504BACKGROUND

  • Schmidt H, Hoyer D, Wilhelm J, Soffker G, Heinroth K, Hottenrott K, Said SM, Buerke M, Muller-Werdan U, Werdan K. The alteration of autonomic function in multiple organ dysfunction syndrome. Crit Care Clin. 2008 Jan;24(1):149-63, ix. doi: 10.1016/j.ccc.2007.10.003.

    PMID: 18241783BACKGROUND

  • Wieske L, Kiszer ER, Schultz MJ, Verhamme C, van Schaik IN, Horn J. Examination of cardiovascular and peripheral autonomic function in the ICU: a pilot study. J Neurol. 2013 Jun;260(6):1511-7. doi: 10.1007/s00415-012-6818-6. Epub 2012 Dec 30.

    PMID: 23275003BACKGROUND

  • Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

    PMID: 2874900BACKGROUND

  • Pagani M, Montano N, Porta A, Malliani A, Abboud FM, Birkett C, Somers VK. Relationship between spectral components of cardiovascular variabilities and direct measures of muscle sympathetic nerve activity in humans. Circulation. 1997 Mar 18;95(6):1441-8. doi: 10.1161/01.cir.95.6.1441.

    PMID: 9118511BACKGROUND

  • Porta A, Baselli G, Rimoldi O, Malliani A, Pagani M. Assessing baroreflex gain from spontaneous variability in conscious dogs: role of causality and respiration. Am J Physiol Heart Circ Physiol. 2000 Nov;279(5):H2558-67. doi: 10.1152/ajpheart.2000.279.5.H2558.

    PMID: 11045994BACKGROUND

  • Furlan R, Porta A, Costa F, Tank J, Baker L, Schiavi R, Robertson D, Malliani A, Mosqueda-Garcia R. Oscillatory patterns in sympathetic neural discharge and cardiovascular variables during orthostatic stimulus. Circulation. 2000 Feb 29;101(8):886-92. doi: 10.1161/01.cir.101.8.886.

    PMID: 10694528BACKGROUND

  • Cooke WH, Hoag JB, Crossman AA, Kuusela TA, Tahvanainen KU, Eckberg DL. Human responses to upright tilt: a window on central autonomic integration. J Physiol. 1999 Jun 1;517 ( Pt 2)(Pt 2):617-28. doi: 10.1111/j.1469-7793.1999.0617t.x.

    PMID: 10332107BACKGROUND

MeSH Terms

Conditions

Multiple Organ FailureCritical Illness

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Ferdinando Raimondi, Director

    Azienda Ospedaliera "L.Sacco"

    STUDY CHAIR

  • Riccardo Colombo, Consultant

    Azienda Ospedaliera "L.Sacco"

    PRINCIPAL INVESTIGATOR

  • Stefano Guzzetti, Director

    Azienda Ospedaliera "L.Sacco"

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 29, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

IT(2)