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

Surgery--Complications Clinical Trial

— VFC COLORECTAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04367987
• Other study ID #: Local/2018/MB-01
• Status: Recruiting
• Start date: June 17, 2020
• Est. completion date: June 2024

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Martin Bertrand
• Phone: 04.66.68.68.09
• Email: martin.bertrand[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of variability of the heart rate between Day-1 to Day 7	Measured by power spectral density; ratio of the high to low frequencies	Day 7
Primary	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	Abdominal-pelvic imagery	Hospital discharge (maximum Day 7)
Primary	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	Abdominal-pelvic imagery	Hospital discharge (maximum Day 7)
Secondary	Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and presence of intra abdominal abscess	diagnosed on CT-scan	Hospital discharge (maximum Day 7)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Correlation between the rate of variability of the heart rate between Day-1 to Day 7 and death rate		Hospital discharge (maximum Day 7)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)