NCT04367987RecruitingNot Applicable
Variability of Heart Rate as a Marker of Complication of Colorectal Surgery
Centre Hospitalier Universitaire de Nīmes1 site in 1 country117 target enrollmentStarted: June 17, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Patients undergoing colorectal surgery
Intervention: Heart Rate Variability (Diagnostic Test)
Outcomes
Primary Outcomes
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)
Abdominal-pelvic imagery
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)
Abdominal-pelvic imagery
Rate of variability of the heart rate between Day-1 to Day 7
Time Frame: Day 7
Measured by power spectral density; ratio of the high to low frequencies
Secondary Outcomes
- 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 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 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 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 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 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 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 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 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 heart disease(Hospital discharge (maximum Day 7))
Investigators
Study Sites (1)
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