Preventing Oxidative stress-induced ischemic injury and systemic inflammation complications during and after invasive cardiac surgery with Alkaline Phosphatase (APPIRED III)

Preventing Oxidative stress-induced ischemic injury and systemic inflammation complications during and after invasive cardiac surgery with Alkaline Phosphatase (APPIRED III) - RESCAP to prevent complications in heart surgery

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49105

Enrollment

150

Registered

2019-06-19

Start date

2017-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal failure systemic inflammatory response

Interventions

alkaline phosphatase (AP)

cardiothoracic surgery

inflammation

kidney injury/ kidney failure

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: A potential subject must meet all of the following criteria to participate in the study: 1. greater than 21 years of age (legal adult in Singapore) 2. Undergoing cardiac surgery with planned cardiopulmonary bypass 3. EUROSCORE II greater than or equal 3 4. Ability to provide informed consent (not incapacitated)

Exclusion criteria

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 urinary albumin excretion of >=30 mg/day, or equivalent or estimated glomerular filtration rate lower than 60 ml/min/1.73 m2 ( CKD stage > 2) 3. Patients who are pregnant 4. Concurrent enrolment in another clinical trial 5. Known allergic reaction to bovine alkaline phosphatase

Design outcomes

Primary

Measure	Time frame
This study has a so-called composite outcome, with a combination of the parameters described below at OR/OR level: Reduction of actual morbidity and mortality numbers. OR Reduction of the post-surgical complications such as AKI, acute renal failure by intravenous administration of RESCAP (alkaline phosphatase) in comparison with the placebo-group. Reduction will be measured to known blood parameters and renal function parameters, AKIN > 2 ( 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 >=50 percent 10 or a drop in urine output to 0.5 ml/kg/hour for 6 hours) OR demonstrate that time to extubation [ defined as removal of endotracheal tube] is reduced OR reduce GI Complications : defined as demonstrable nasogastric bleeding > 12 hours , malena or positive fecal occult blood OR reduce neurological complications : defined as focal neurological deficit of central origin lasting more than 72 hours demonstrable on a CT scan.	—

Measure

Time frame

This study has a so-called composite outcome, with a combination of the parameters described below at OR/OR level: Reduction of actual morbidity and mortality numbers. OR Reduction of the post-surgical complications such as AKI, acute renal failure by intravenous administration of RESCAP (alkaline phosphatase) in comparison with the placebo-group. Reduction will be measured to known blood parameters and renal function parameters, AKIN > 2 ( 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 >=50 percent 10 or a drop in urine output to 0.5 ml/kg/hour for 6 hours) OR demonstrate that time to extubation [ defined as removal of endotracheal tube] is reduced OR reduce GI Complications : defined as demonstrable nasogastric bleeding > 12 hours , malena or positive fecal occult blood OR reduce neurological complications : defined as focal neurological deficit of central origin lasting more than 72 hours demonstrable on a CT scan.

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Secondary

Measure	Time frame
outcomes associated to CPB and AP intervention including 1) the incidence of renal replacement therapy, b) duration of renal replacement therapy, c) days spent in the ICU and time spent in hospital, and d) the incidence of arrhythmias in the two groups 2) Plasma levels of a set of inflammatory markers (IL-6, IL-8, IL-10, TNF-alpha) and increase endogenous alkaline phosphatase levels and kidney function markers (IL18, NGAL, TIMP-1, GFR) in the control and AP treated groups. 3. Following the finalisation of APPIRED III study: Estimate the incremental cost effectiveness ratio (ICER) by comparing the costs and effectiveness between AP and placebo groups.	—

Measure

Time frame

outcomes associated to CPB and AP intervention including 1) the incidence of renal replacement therapy, b) duration of renal replacement therapy, c) days spent in the ICU and time spent in hospital, and d) the incidence of arrhythmias in the two groups 2) Plasma levels of a set of inflammatory markers (IL-6, IL-8, IL-10, TNF-alpha) and increase endogenous alkaline phosphatase levels and kidney function markers (IL18, NGAL, TIMP-1, GFR) in the control and AP treated groups. 3. Following the finalisation of APPIRED III study: Estimate the incremental cost effectiveness ratio (ICER) by comparing the costs and effectiveness between AP and placebo groups.

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Countries

Australia, Austria, Belgium, Germany, Italy, Malaysia, Netherlands, Portugal, Russian Federation, Singapore

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)