EUCTR2016-002663-33-NL
Active, not recruiting
Phase 1
Preventing Oxidative stress-induced Ischemic Injury and Systemic Inflammation complications during and after invasive Cardiac surgery with Alkaline Phosphatase (APPIRED III) - APPIRED III
Conditionssystemic inflammation as side-effect of heart-lung machine during cardiac surgeryMedDRA version: 20.0 Level: LLT Classification code 10017501 Term: Functional disturbances following cardiac surgery System Organ Class: 100000004863MedDRA version: 20.0 Level: LLT Classification code 10062357 Term: SIRS System Organ Class: 100000004867Therapeutic area: Body processes [G] - Immune system processes [G12]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- systemic inflammation as side-effect of heart-lung machine during cardiac surgery
- Sponsor
- Alloksys Life Sciences BV
- Enrollment
- 1250
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A potential subject must meet all of the following criteria to participate in the study:
- •1\.\> 21 years of age (legal adult in Singapore)
- •2\.Undergoing cardiac surgery with planned cardiopulmonary bypass
- •3\.EuroSCORE II \>\= 3
- •4\.Ability to provide informed consent (not incapacitated)
- •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 625
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Any subjects meeting the following criteria at baseline will be excluded:
- •1\.Already on renal replacement therapy
- •2\.Patients with chronic kidney disease defined as estimated glomerular filtration rate \[eGFR] \< 30 ml/min/1\.73 m2\. \[ CKD stage \> 3]
- •3\.Patients who are pregnant
- •4\.Concurrent enrolment in another clinical trial
- •5\. Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian, vegan, or does not consume any bovine meat products (beef) that is, the patient may not be tolerant for bovine proteins
- •6\. Patients with ongoing infections or current use of steroids.
Outcomes
Primary Outcomes
Not specified
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