Clinical trial NCT04367987: Variability of Heart Rate as a Marker of Complication of Colorectal Surgery
Official title: Variability of Heart Rate as a Marker of Complication of Colorectal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery--Complications
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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

Primary outcomes:
measure: Rate of variability of the heart rate between Day-1 to Day 7
timeFrame: Day 7
measure: 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
timeFrame: Hospital discharge (maximum Day 7)
measure: 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
timeFrame: Hospital discharge (maximum Day 7)
Secondary outcomes:
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of gut wall abscess
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pneumonia
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of urinary tract infection
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of central venous catheter infection
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal hematoma
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of hemorrhagic shock
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of deep vein thrombosis
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of pulmonary embolism
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of acute pulmonary edema
timeFrame: Hospital discharge (maximum Day 7)
measure: Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of heart disease
timeFrame: Hospital discharge (maximum Day 7)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Martin Bertrand
role: PRINCIPAL_INVESTIGATOR
References: