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Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

PHASE2PHASE3RECRUITING

Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.

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Study details:

After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Undergoing cardiac surgery with planned cardiopulmonary bypass

Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned

Ability to provide informed consent (not incapacitated)

Exclusion criteria

Already on renal replacement therapy

Patients with chronic kidney disease defined as estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 [ CKD stage > 3 ]

Patients who are pregnant or lactating

Concurrent enrollment in another clinical trial

Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan

Patients with ongoing infections or current use of steroids

Patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. TEVAR)

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Eligibility

Age eligible for study : 21 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2017-11-01

Primary completion: 2025-09-30

Study completion finish: 2026-03-31

Study type

PREVENTION

Phase

PHASE2

PHASE3

Trial ID

NCT03050476

Intervention or treatment

DRUG: RESCAP®

DRUG: placebo

Conditions

• Systemic Inflammation
• Cardiopulmonary-bypass

Condition: Systemic Inflammation, Cardiopulmonary-bypass
DRUG: RESCAP® and other drugs
Clayton, Melbourne, Australia
Sponsor: Alloksys Life Sciences B.V.

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Dept. Cardiothoracic Surgery , Monash Medical Centre

Research sites nearby

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Dept. Cardiothoracic Surgery , Monash Medical Centre
Clayton, Melbourne, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: RESCAP® Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion with a sum of 10,000 IU/day over the next 24 or 96 hours.	DRUG: RESCAP® intravenous application before, during, and for 24 or 96 hours after heart surgery
PLACEBO_COMPARATOR: Placebo Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.	DRUG: placebo intravenous application before, during, and for 24 or 96 hours after heart surgery

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of patients with acute kidney injury	AKIN criteria: Rise in serum creatinine of by 0.3 mg/dl or 26 µmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of more than 50 percent or a drop in urine output to 0.5 ml/kg/hour for 6 hours	90 days
reach haemodynamic stability	Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability	7 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
cost-related outcome	Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay	30 days
levels of a set of inflammatory markers	IL-6, IL-8, IL-10, IL-17, TNF-alpha	4 days

Frequently Asked Questions

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References

Clinical Trials Gov: Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase