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

• Conditions: Surgery--Complications
• Interventions: Diagnostic Test: Heart Rate Variability

• Registration Number: NCT04367987
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Study Start: 2020-06-17
• Status Verified: 2021-08
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-21
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing colorectal surgery	Heart Rate Variability	-

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France