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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Recruiting
CT.gov ID
NCT04367987
Collaborator
(none)
117
1
47.5
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Heart Rate Variability

Study Design

Study Type:
Observational
Anticipated Enrollment :
117 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Variability of Heart Rate as a Marker of Complication of Colorectal Surgery
Actual Study Start Date :
Jun 17, 2020
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Rate of variability of the heart rate between Day-1 to Day 7 [Day 7]

    Measured by power spectral density; ratio of the high to low frequencies

  2. 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 [Hospital discharge (maximum Day 7)]

    Abdominal-pelvic imagery

  3. 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 [Hospital discharge (maximum Day 7)]

    Abdominal-pelvic imagery

Secondary Outcome Measures

  1. 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)]

    diagnosed on CT-scan

  2. 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)]

  3. 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)]

  4. 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)]

  5. 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)]

  6. 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)]

  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)]

  8. Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate [Hospital discharge (maximum Day 7)]

  9. 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)]

  10. 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)]

  11. 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)]

  12. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nimes Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Martin Bertrand, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT04367987
Other Study ID Numbers:
  • Local/2018/MB-01
First Posted:
Apr 29, 2020
Last Update Posted:
Mar 21, 2022
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 21, 2022