Cardiac DiseaseNCT06484907
Predicting CSA-AKI With ACTA-PORT Score
An observational study of Cardiac Disease and Blood Transfusion, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In the scope of this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Blood Transfusion, Acute Kidney Injury
- How many people
- 467 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having open heart surgery by using cardiopulmonary bypass pump in Ankara Bilkent City Hospital between 01 July 2024 - 01 November 2024.
Who may be able to join
- Patients over 18 years old
- Patients having open heart surgery
- Patients undergoing surgery by using cardiopulmonary bypass pump
Who cannot join
- Patients under 18 years old
- Patients diagnosed with kidney disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
About this study
Official title: Predictive Power of the ACTA-PORT Score for Cardiac Surgery-Associated Acute Kidney Injury: A Prospective Observational Study
In the scope of this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.
Read the detailed description
ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) score is a simple, reliable, and validated tool used to predict the risk of transfusion in patients undergoing heart surgery. In calculating ACTA-PORT score, age, gender, hemoglobin, body surface area, EuroSCORE, creatinine, and type of operation are used.
In this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.
The files of patients undergoing open heart surgery in the cardiovascular surgical operating rooms of Ankara Bilkent City Hospital, along with anesthesia records, transfusion records, and test results identified through the Hospital Information Management System, will be prospectively evaluated. Data will be collected after patients are admitted to the intraoperative and postoperative intensive care unit.
- Conditions
- Cardiac Disease, Blood Transfusion, Acute Kidney Injury
- Keywords
- Cardiopulmonary Bypass, Cardiac Surgery, Transfusion, Acute Kidney Injury, ACTA PORT
- Medical subject headings
- Heart Diseases, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
KDIGO AKI Staging
KDIGO is in the process of developing the Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD). ///// Stage 1: Serum creatinine 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5 mmol/l) increase or Urine output <0.5 ml/kg/h for 6-12 hours ////// Stage 2: Serum creatinine 2.0-2.9 times baseline or <0.5 ml/kg/h for ≥12 hours /////// Stage 3: Serum creatinine 3.0 times baseline or Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l) or Initiation of renal replacement therapy or in patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m² or Urine output <0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours
Measured: Preoperative (last week before operation) and daily after the operation for 7 days
Secondary outcomes (6)
Mechanical Ventilation Duration
The duration the patient remains intubated from surgery to extubation
Measured: the duration after surgery up to a month
Intensive Care Duration
The duration the patient remains in intensive care unit after surgery
Measured: the duration after surgery up to a month
Hospital Stay Duration
The duration the patient stays in the hospital after surgery until discharge
Measured: the duration after surgery up to a month
Mortality
If the patient dies within 1 month or not
Measured: the duration after surgery up to a month
Complications
Cardiac, Pulmonary, Neurological, Infectious, Thrombotic complications and Presence of MODS (Multiple Organ Dysfunction Syndrome) / SIRS (Systemic Inflammatory Response Syndrome)
Measured: the duration after surgery up to a month
Reoperation Necessity
The need for reoperation due to bleeding
Measured: the duration after surgery up to a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024
- Primary completion15 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansuhan AKAR YİĞİT, Ankara City Hospital Bilkent
- Investigators
- Zeliha Asli DEMIR, Ph.D, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484907
- Sponsor's protocol ID
- ABCH-AR-CAY-01
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Power of the ACTA-PORT Score for Cardiac Surgery-Associated Acute Kidney Injury: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06484907
- Acronym / sponsor ID
- ABCH-AR-CAY-01
- Conditions
- Cardiac Disease, Blood Transfusion, Acute Kidney Injury
- Keywords
- Cardiopulmonary Bypass, Cardiac Surgery, Transfusion, Acute Kidney Injury, ACTA PORT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the scope of this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.
Detailed description
ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) score is a simple, reliable, and validated tool used to predict the risk of transfusion in patients undergoing heart surgery. In calculating ACTA-PORT score, age, gender, hemoglobin, body surface area, EuroSCORE, creatinine, and type of operation are used.
In this study, it will be determined whether the ACTA-PORT (Association of Cardiothoracic Anesthetists perioperative risk of blood transfusion) scoring system can predict the incidence of events in other organ systems, and the feasibility of conducting multiple assessments using a single simple score will be investigated.
The files of patients undergoing open heart surgery in the cardiovascular surgical operating rooms of Ankara Bilkent City Hospital, along with anesthesia records, transfusion records, and test results identified through the Hospital Information Management System, will be prospectively evaluated. Data will be collected after patients are admitted to the intraoperative and postoperative intensive care unit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having open heart surgery by using cardiopulmonary bypass pump in Ankara Bilkent City Hospital between 01 July 2024 - 01 November 2024.
Key inclusion criteria (3 listed)
- Patients over 18 years old
- Patients having open heart surgery
- Patients undergoing surgery by using cardiopulmonary bypass pump
Key exclusion criteria (2 listed)
- Patients under 18 years old
- Patients diagnosed with kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KDIGO AKI Staging
Time frame: Preoperative (last week before operation) and daily after the operation for 7 days
KDIGO is in the process of developing the Clinical Practice Guideline for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD). ///// Stage 1: Serum creatinine 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5 mmol/l) increase or Urine output <0.5 ml/kg/h for 6-12 hours ////// Stage 2: Serum creatinine 2.0-2.9 times baseline or <0.5 ml/kg/h for ≥12 hours /////// Stage 3: Serum creatinine 3.0 times baseline or Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l) or Initiation of renal replacement therapy or in patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m² or Urine output <0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours
6 secondary outcomes
Mechanical Ventilation Duration
Time frame: the duration after surgery up to a month
Intensive Care Duration
Time frame: the duration after surgery up to a month
Hospital Stay Duration
Time frame: the duration after surgery up to a month
Mortality
Time frame: the duration after surgery up to a month
Complications
Time frame: the duration after surgery up to a month
Reoperation Necessity
Time frame: the duration after surgery up to a month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha Asli DEMIR, Ph.D principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Blood Transfusion, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KDIGO AKI Staging (time frame: Preoperative (last week before operation) and daily after the operation for 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.