Major Abdominal SurgeryNCT02375412
Preoperative Measurement of Heart Rate Variability as a Predictor of Postoperative Outcome
An observational study of Major Abdominal Surgery, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Pre-operative measurement of heart rate variability
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective major abdominal surgery.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, 708 52
About this study
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
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.
Read the 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.
- Conditions
- Major Abdominal Surgery
- Being tested
- Pre-operative measurement of heart rate variability
- Keywords
- heart rate variability, post-operative outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative measurement of heart rate variabilityProcedure or surgery
Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative HRV group | Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery. Receives: Procedure: Pre-operative measurement of heart rate variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
The length of hospitalization
Length of hospital stay will be obtained from the patient record.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375412
- Sponsor's protocol ID
- FNO-KARIM-2
- Status last verified
- Mar 2017
- First submitted
- 24 Feb 2015
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 18042846Mazzeo 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.
PubMed 21658013Heart 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.
PubMed 8737210
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02375412
- Acronym / sponsor ID
- FNO-KARIM-2
- Conditions
- Major Abdominal Surgery
- Keywords
- heart rate variability, post-operative outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative HRV group | – | Procedure: Pre-operative measurement of heart rate variabilityPre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective major abdominal surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- pregnant or lactating women
- age below 21 years of age
- emergency surgery
- American Society of Anesthesiology (ASA) classification 1
- sepsis and septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative measurement of heart rate variabilityPre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery | Procedure or surgery | Pre-operative HRV group |
Primary outcome
Pre-defined postoperative complications for up to 28 days after surgery
Time frame: 24 months
The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.
1 secondary outcome
The length of hospitalization
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Background: PubMed 18042846Laitio 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.
- Background: PubMed 21658013Mazzeo 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.
- Background: PubMed 8737210Heart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Abdominal Surgery, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-defined postoperative complications for up to 28 days after surgery (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.