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Transplanted-like Heart in Critical Ill Patients

NCT01930669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-11-05

No results posted yet for this study

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.

Conditions

  • Autonomic Nervous System Dysfunction in Critically Ill

Interventions

OTHER

Gravitational sympathetic stimulus

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.

Sponsors & Collaborators

  • Regione Lombardia

    collaborator OTHER

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Ferdinando Raimondi, Director · Azienda Ospedaliera "L.Sacco"

  • Riccardo Colombo, Consultant · Azienda Ospedaliera "L.Sacco"

  • Stefano Guzzetti, Director · Azienda Ospedaliera "L.Sacco"

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Italy

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 NCT01930669 on ClinicalTrials.gov