Variability of Heart Rate as a Marker of Complication of Colorectal Surgery (VFC COLORECTAL)

Heart rate variability reflects the autonomic nervous system on the intrinsic activity of sinus node cells. Sympathetic hyperactivity is an adaptation to stress, while parasympathetic hyperactivity is present at rest. Thus, any variability in the heart frequency rate reflects variations in sympathetic and parasympathetic components in the autonomic nervous system. Failure to return to normal or a reduction in the variability of the heart rate in the postoperative period is correlated with complications in colorectal surgery.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications
• Intervention / Treatment: Diagnostic test: Heart Rate Variability

• Study Type: Observational
• Enrollment (Anticipated): 117

Contacts and Locations

• Study Contact: Name: Martin Bertrand; Phone Number: 04.66.68.68.09; Email: martin.bertrand@chu-nimes.fr

Study Locations

• France
  • Nîmes, France
    • Recruiting
    • CHU de NIMES
    • Principal Investigator: Martin Bertrand
    • Sub-Investigator: Pauline Balenghien
    • Sub-Investigator: Mihane Nayeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing scheduled colorectal resection or operated on in the digestive surgery department of the CHU Nîmes

Description

Inclusion Criteria:

• Patients operated for a scheduled colorectal resection due to cancer, diverticulitis, or Chronic Inflammatory Bowel Disease,
• American Society of Anesthesiologists score 1-2
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

• Patient taking antidepressants, antipsychotics, antihypertensive beta blocker type, anti-arythmic or oral contraception
• Uncontrolled diabetes or associated with a neuropathy
• Arrhythmias and conduction disturbances, , coronaropathy and heart failure, kidney failure
• Neuropathies
• Pacemaker or defibrillator
• The subject is participating in another interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing colorectal surgery	Diagnostic test: Heart Rate Variability; Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of variability of the heart rate between Day-1 to Day 7	Measured by power spectral density; ratio of the high to low frequencies	Day 7
Correlation between the rate of variability of the heart rate between Day-1 to Day 7and anastomotic fistula diagnosed according to Center for Diseases Control criteria after scheduled colorectal surgery	Abdominal-pelvic imagery	Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and peri-anastomotic fluid collections after scheduled colorectal surgery	Abdominal-pelvic imagery	Hospital discharge (maximum Day 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess	diagnosed on CT-scan	Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscess		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumonia		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of urinary tract infection		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of central venous catheter infection		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal hematoma		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shock		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of deep vein thrombosis		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolism		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of acute pulmonary edema		Hospital discharge (maximum Day 7)
Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart disease		Hospital discharge (maximum Day 7)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Martin Bertrand, CHU NIMES

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Local/2018/MB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No