Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

  • STATUS
    Recruiting
  • End date
    Sep 25, 2022
  • participants needed
    1250
  • sponsor
    Alloksys Life Sciences B.V.
Updated on 25 January 2021
Investigator
Ruud Brands, PhD
Primary Contact
Institut Jantung Negara (IJN , Natl. Heart Inst.) (4.8 mi away) Contact
+15 other location

Summary

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.

Description

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, late extubation, gastrointestinal or neurological complications or death within 30 days.

Details
Condition Cardiopulmonary Bypass, Systemic Inflammation, heart/lung bypass
Treatment Placebo, bRESCAP
Clinical Study IdentifierNCT03050476
SponsorAlloksys Life Sciences B.V.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note