Preoperative Measurement of Heart Rate Variability as a Predictor of Postoperative Outcome

NCT02375412 | Completed

• 1 other identifier: FNO-KARIM-2
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Abdominal Surgery

Keywords

heart rate variability; post-operative outcome

Outcome Measures

Primary Outcomes (1)

• Pre-defined postoperative complications for up to 28 days after surgery

  The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

  24 months

Secondary Outcomes (1)

• The length of hospitalization

  24 months

Study Arms (1)

Pre-operative HRV group

Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery.

Procedure: Pre-operative measurement of heart rate variability

Interventions

Pre-operative measurement of heart rate variability PROCEDURE

Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery

Pre-operative HRV group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective major abdominal surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

Location

Related Publications (3)

• 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.

  PMID: 18042846 BACKGROUND

• 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: 21658013 BACKGROUND

• 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.

  PMID: 8737210 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)