EUCTR2016-002663-33-BE
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)
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: 100000004863Therapeutic 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\.Additive 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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