Autonomic Nervous System Dysfunction in Critically Ill | Transplanted-like Heart in Critical Ill Patients
Autonomic Nervous System Dysfunction in Critically Ill research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 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 Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Autonomic Nervous System Dysfunction in Critically Ill
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Gravitational sympathetic stimulusAutonomic 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
All patientsTo measure the autonomic nervous system activity elicited by a gravitational sympathetic stimulus in critically ill
Start Date: August 2013
Completed Date: September 2014
Primary Outcome: Incidence of autonomic nervous system dysfunction in critical ill patients
Secondary Outcome: to measure the occurrence of ANS failure in subgroups
Study sponsors, principal investigator, and references
Principal Investigator: Ferdinando Raimondi, Director
Lead Sponsor: ASST Fatebenefratelli Sacco
Collaborator: Regione Lombardia
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. Review.