Clinical trial NCT02375412: Preoperative Measurement of Heart Rate Variability as a Predictor of Postoperative Outcome
Official title: Preoperative Evaluation of Autonomic Nervous System by Heart Rate Variability as a Predictor of Postoperative Outcome in the Patient Undergoing Major Elective Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Abdominal Surgery
Keywords: heart rate variability
post-operative outcome
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major abdominal surgery.

Brief summary: The purpose of the study is to confirm the hypothesis that a dysfunction of the autonomic nervous system could complicate the postoperative course in the patient undergoing surgery. Measurement of heart rate variability (HRV) is a non-invasive method for evaluation of the autonomic nervous system.

Detailed description: The autonomic nervous system (ANS) plays an important role in the maintenance of systemic homeostasis. The homeostasis is modified continually by internal and external stimuli to which the autonomic nervous system modulates the response of organism by tight control on essential functions such as circulation, respiration, hormonal secretion and thermoregulation. Dysfunction of the autonomic nervous system could complicate the perioperative course in the patient undergoing surgery; therefore it should be considered as another risk factor during preoperative evaluation. Nowadays the evaluation of the autonomic nervous system function like a tool for prediction postoperative outcome is not considered in daily anaesthesiology practice. Measurement of heart rate variability (HRV) is a method for evaluation the autonomic nervous system function. It is a non-invasive method that provides information about the autonomic regulation of organism and thus it identifies patients with the autonomic nervous system dysfunction.

Eligibility criteria: Inclusion Criteria:

* 21 years of age and above
* anticipated duration of surgery more than 120 minutes
* estimated blood loss exceeding more than 15% of blood volume
* American Society of Anesthesiology (ASA) classification 2 or 3

Exclusion Criteria:

* pregnant or lactating women
* age below 21 years of age
* emergency surgery
* American Society of Anesthesiology (ASA) classification 1
* sepsis and septic shock
* severe cardiac arrhythmias

Primary outcomes:
measure: Pre-defined postoperative complications for up to 28 days after surgery
timeFrame: 24 months
Secondary outcomes:
measure: The length of hospitalization
timeFrame: 24 months
Other outcomes:
Locations:
city: Ostrava-Poruba
country: Czech Republic
facility: University Hospital Ostrava
Study officials:
References:
citation: Laitio T, Jalonen J, Kuusela T, Scheinin H. The role of heart rate variability in risk stratification for adverse postoperative cardiac events. Anesth Analg. 2007 Dec;105(6):1548-60. doi: 10.1213/01.ane.0000287654.49358.3a.
citation: 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.
citation: Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.