Study on Alkaline Phosphatase to Prevent Inflammation and Kidney Injury in Patients Undergoing Open-Heart Surgery

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What is this study about?

This clinical trial is focused on patients undergoing open-heart surgery, specifically those who experience systemic inflammation as a side effect of using a heart-lung machine during the procedure. The study is investigating a treatment called RESCAP iv, which contains an active substance known as alkaline phosphatase, bovine. This treatment is given as a solution for injection or infusion. The purpose of the study is to see if RESCAP iv can help reduce complications that occur during and after heart surgery.

Participants in the study will receive either the RESCAP iv treatment or a placebo, which looks the same but does not contain the active substance. The study will monitor how quickly patients reach stability in the intensive care unit (ICU) and whether the treatment can reduce the occurrence and severity of acute kidney injury after surgery. Acute kidney injury is a condition where the kidneys suddenly stop working properly, and it can be measured by changes in blood tests and urine output.

The study will follow patients for up to 90 days after their surgery to assess the effects of the treatment. The goal is to determine if RESCAP iv can improve recovery and reduce the risk of complications associated with heart surgery. Participants will be closely monitored throughout the study to ensure their safety and to gather important information about the treatment’s effectiveness.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age over 21, undergoing cardiac surgery with planned use of a heart-lung machine, and a EuroSCORE II of 3 or higher.

Written informed consent is required before participation.

2 pre-surgery preparation

Preparation for cardiac surgery includes standard pre-operative procedures.

The study involves the administration of RESCAP iv or a placebo, which is identical in appearance but lacks the active substance.

3 administration of medication

The medication is given as a solution for injection or infusion through an intravenous bolus injection or IV infusion.

The active substance in RESCAP iv is alkaline phosphatase, derived from bovine sources.

4 post-surgery monitoring

Monitoring occurs in the intensive care unit (ICU) for up to 12 days.

The severity of illness is assessed using the SOFA score, with outcomes compared after 72 hours in the ICU.

5 assessment of kidney function

The study evaluates the incidence and extent of acute kidney injury (AKI) after surgery, using the AKIN criteria.

AKI is checked within 30 days and again after 90 days post-surgery.

6 completion of study participation

Participation concludes after the final assessment of kidney function and overall health outcomes.

The study is estimated to end by March 31, 2026.

Who Can Join the Study?

You must be over 21 years old.
You are having heart surgery that will use a machine to help your heart and lungs work during the operation.
Your EuroSCORE II, which is a way to measure the risk of heart surgery, must be 3 or higher.
You must be able to understand and agree to participate in the study, meaning you are not mentally incapacitated.
You must have signed a written agreement to take part in the study and agree to follow the study’s rules.

Who Cannot Join the Study?

Patients who are not experiencing systemic inflammation as a side effect of the heart-lung machine during heart surgery cannot participate. Systemic inflammation means that the whole body is experiencing swelling and irritation.
Patients who are not in the age range specified for the study cannot participate. The study includes certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
CHU Saint Pierre	Brussels	Belgium
Az Maria Middelares Gent	Gent	Belgium
Jessa Ziekenhuis	Hasselt	Belgium

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.12.2017
Belgium	Not yet recruiting	01.12.2017

Trial locations

Investigated drugs:

Alkaline Phosphatase, Bovine

RESCAP® is a medication being studied for its potential to reduce the time it takes for patients to reach stability while in the Intensive Care Unit (ICU) after cardiac surgery. The effectiveness of this medication is assessed by monitoring the severity of illness using a specific scoring system over a period of 12 days. The goal is to see if patients recover more quickly when treated with this medication.

Alkaline Phosphatase is being tested for its ability to decrease the occurrence and severity of acute kidney injury following heart surgery. This medication aims to protect the kidneys from damage that can occur during and after surgery, potentially improving patient outcomes by reducing complications related to kidney function.

Systemic Inflammation as a Side-Effect of Heart-Lung Machine During Cardiac Surgery – This condition occurs when the use of a heart-lung machine during cardiac surgery triggers an inflammatory response throughout the body. The machine, which temporarily takes over the function of the heart and lungs, can cause the immune system to react, leading to widespread inflammation. This inflammation can affect multiple organs and systems, potentially causing complications. The severity of the inflammation can vary, and it may lead to symptoms such as fever, swelling, and changes in blood pressure. The condition is monitored closely in the intensive care unit to manage and mitigate its effects.

Trial ID:

2025-520551-84-00

Protocol code:

NUH-ALS-2015-04

NCT ID:

NCT03050476

Trial Phase:

Therapeutic confirmatory (Phase III)

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