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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03050476




Registration number
NCT03050476
Ethics application status
Date submitted
24/01/2017
Date registered
13/02/2017

Titles & IDs
Public title
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Scientific title
Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
Secondary ID [1] 0 0
NUH-ALS-2015-04
Universal Trial Number (UTN)
Trial acronym
APPIRED-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Inflammation 0 0
Cardiopulmonary-bypass 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RESCAP®
Treatment: Drugs - placebo

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.

Placebo comparator: Placebo - Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.


Treatment: Drugs: RESCAP®
intravenous application before, during, and for 24 or 96 hours after heart surgery

Treatment: Drugs: placebo
intravenous application before, during, and for 24 or 96 hours after heart surgery
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with acute kidney injury
Timepoint [1] 0 0
90 days
Primary outcome [2] 0 0
reach haemodynamic stability
Timepoint [2] 0 0
7 days
Secondary outcome [1] 0 0
cost-related outcome
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
levels of a set of inflammatory markers
Timepoint [2] 0 0
4 days

Eligibility
Key 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)
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
1250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Melbourn
Recruitment hospital [1] 0 0
Dept. Cardiothoracic Surgery , Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
VIC 3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Genk
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Hasselt
Country [7] 0 0
Germany
State/province [7] 0 0
Bavaria
Country [8] 0 0
Germany
State/province [8] 0 0
Leipzig
Country [9] 0 0
Italy
State/province [9] 0 0
Roma
Country [10] 0 0
Malaysia
State/province [10] 0 0
Kuala Lumpur
Country [11] 0 0
Netherlands
State/province [11] 0 0
Limburg
Country [12] 0 0
Netherlands
State/province [12] 0 0
Eindhoven
Country [13] 0 0
Portugal
State/province [13] 0 0
Lisboa
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Kazan
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Saint Petersburg
Country [16] 0 0
Russian Federation
State/province [16] 0 0
St Petersburg
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alloksys Life Sciences B.V.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Aix Scientifics
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ruud Brands, PhD
Address 0 0
Alloksys Life Sciences BV . President
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruud Brands, PhD
Address 0 0
Country 0 0
Phone 0 0
+31 647 228 395
Fax 0 0
Email 0 0
ruud@alloksys.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03050476