Variability of Heart Rate as a Marker of Complication of Colorectal Surgery

NCT04367987 | Unknown

• 1 other identifier: Local/2018/MB-01
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal 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 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)

Study Arms (1)

Patients undergoing colorectal surgery

Diagnostic Test: Heart Rate Variability

Interventions

Heart Rate Variability DIAGNOSTIC_TEST

Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software

Patients undergoing colorectal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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 refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

RECRUITING

Study Officials

• Martin Bertrand

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Bertrand

CONTACT

04.66.68.68.09; martin.bertrand@chu-nimes.fr

Study Design

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

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: June 17, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 21, 2022

Record last verified: 2021-08

Locations

FR (1)