EUCTR2018-001917-34-ES
Active, not recruiting
Phase 1
Cardiac complications associated to perioperative hyperoxia in elective colorectal surgery - TropoO2
ConditionsCardiovascular complications after colorectal surgeryMedDRA version: 20.1 Level: LLT Classification code 10007648 Term: Cardiovascular disease, unspecified System Organ Class: 100000004849MedDRA version: 20.0 Level: LLT Classification code 10050322 Term: Oxygen supplementation System Organ Class: 100000004865Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cardiovascular complications after colorectal surgery
- Sponsor
- Consorci Mar Parc de Salut de Barcelona
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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