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Recruiting NCT04367987

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

— Observational Surgery--Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Heart Rate Variability.
Who it may be relevant to
Registry conditions: Surgery--Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Heart Rate Variability
    Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software

Primary outcome measures

  • Rate of variability of the heart rate between Day-1 to Day 7 [Time frame: 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 [Time frame: 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 [Time frame: Hospital discharge (maximum Day 7)]
Secondary outcome measures (12)
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Hospital discharge (maximum Day 7)]
  • Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Hospital discharge (maximum Day 7)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de Nimes — Nîmes

Identifiers

NCT: NCT04367987 · Local/2018/MB-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗