High oxygen administration and cardiac complications in colorectal surgery

Phase 1

• Conditions: MedDRA version: 20.0 Level: LLT Classification code 10050322 Term: Oxygen supplementation System Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Cardiovascular complications after colorectal surgery; MedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849

• Registration Number: EUCTR2018-001917-34-ES
• Lead Sponsor: Consorci Mar Parc de Salut de Barcelona

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-05
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

- Elective colorectal surgery
- Age > 18 year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

- Pregnancy
- severe COPD
- Acute cardiovascular syndrom 6 weeks prior surgery
- Hemodialysis
- General anesthesia administered 1 month prior surgery
- The impossibility to sign / to understand the informed consent
- Intraoperative complications that requires mechanical ventilation or vasoactive drugs in the postoperative period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to assess if hyperoxia ( intraoperative FiO2 >80%) increases the postoperative incidence of myocardic injury during first 96 hours after surgery;<br> Secondary Objective: - Cardiovascular complications at 30 days postoperative<br> - Mortality at 30 days postoperative<br> - Cardiovascular complications at 1 year postoperative<br> - Mortality at 1 year postoperative<br> ;<br> Primary end point(s): Myocardial injury, described as:<br> - MINS (myocardial injury after non cardiac surgery)<br> - Acute coronary syndrom ( including acute myocardial infarction, unstable angina and sudden cardiac death)<br> ;Timepoint(s) of evaluation of this end point: 96 hours postoperative

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - New diagnosis of cardiovascular diseases : arrhythmias of new appearance, heart failure, invasive coronary procedure, pulmonary thromboembolism, stroke<br> - Death<br> ;Timepoint(s) of evaluation of this end point: 30 days and 1 year postoperative