Kidney Injury, AcuteNCT05426291
Acute Kidney Damage in Patients Undergoing Open Heart Surgery
An observational study of Kidney Injury, Acute, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aimed to determine whether preoperative biomarkers (Mg, Hgb, CRP, ProBNP) would be helpful in the early diagnosis of CSA-AKI (cardiac surgery-related acute kidney injury) in patients undergoing open heart surgery. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Kidney Injury, Acute
- What is being tested?
- BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2022to 30 May 2024
- How long will I take part?
- 4 Weeks
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged ≥40 years,<85 years) with ASA II-IV who were scheduled for elective open heart surgery under cardiopulmonary bypass (CPB) will be prospectively included in this study. Patients included in the study will be divided into two groups. At least two of the preoperative biomarkers (Mg<0.85 mmol/L, Hgb<8.5 mmol/L, proBNP>480 pg/mL, CRP>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, patients who meet at least two of the preoperative biomarkers (Mg>0.85 mmol/L, Hgb>8.5 mmol/L, proBNP<480 pg/mL, CRP<5 mg/L) Group II will be included in the study.
Who may be able to join
- Elective on-pomp coronary artery bypass
Who cannot join
- Emergency operation,
- Off pump coronary artery bypass
- Revision (repetitive) operation
- Preoperative acute Renal failure
- Preoperative chronic Renal failure
- Preoperative decompansed heart failure
- Valve replacement surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
BakirkoySadiKonuk Training and Searching Hospital
Istanbul, 34147
About this study
Official title: Is It Possible to Predict Acute Kidney Damage in Patients Undergoing Open Heart Surgery in the Preoperative Period?
Aimed to determine whether preoperative biomarkers (Mg, Hgb, CRP, ProBNP) would be helpful in the early diagnosis of CSA-AKI (cardiac surgery-related acute kidney injury) in patients undergoing open heart surgery.
Read the detailed description
An adult patient (aged ≥40 years) with ASA II-IV who was scheduled for elective open heart surgery under cardiopulmonary bypass (CPB) in our clinic between March 1, 2022 and October 30, 2022 will be prospectively included in this study. Patients included in the study will be divided into two groups. At least two of the preoperative biomarkers (Mg<0.85 mmol/L, Hgb<8.5 mmol/L, proBNP>480 pg/mL, CRP>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, patients who meet at least two of the preoperative biomarkers (Mg>0.85 mmol/L, Hgb>8.5 mmol/L, proBNP<480 pg/mL, CRP<5 mg/L) Group II will be included in the study.Standard monitoring such as electrocardiogram, non-invasive blood pressure and pulsoximetric saturation (SpO2), cerebral oximetry (bSO2, NIRS) will be performed in all open heart surgery patients. To prevent possible kidney damage, colloid fluids and mannitol will not be used as prime solution and replacement fluid in both groups. As in routine open heart surgery, mean arterial pressure (MAP) will be allowed to vary between 55 and 70 mmHg, the volume deficit will be replaced with erythrocyte suspension and/or crystalloid replacement in the form of 500 ml boluses, keeping the hematocrit above 25%. In case of need for a vasoactive agent, dopamine and/or adrenaline infusion is started in the standard open heart surgery procedure. After the operation, the patients are transferred to the cardiovascular surgery intensive care unit (ICU) under the effect of orotracheal intubation and conscious anesthesia. Demographic characteristics of patients (age, gender, height, weight, body mass index, diabetes mellitus, hypertension, peripheral vascular disease, smoking history, hyperlipidemia, atrial fibrillation history, left ventricular ejection fraction) European Cardiac Operative Risk Assessment System (EuroSCORE), baseline bSo2, preoperative magnesium, proBNP, CRP, hemoglobin, serum urea, creatinine value and calculated glomerular filtration rate, cystatin C value, diagnosis, surgical procedure, cardiopulmonary bypass time and cross clamp time will be recorded. Patients with high preoperative Cystatin C levels will be excluded from the study.Serum urea, creatinine concentration and GFR values will be evaluated and recorded at admission to the hospital, one day before surgery, admission to the intensive care unit, and in the mornings of the following 7 days. Cystatin C concentration will be evaluated and recorded the day before surgery, on the first postoperative day (24 hours after surgery).Heart apex, mean arterial pressure, Spo2, bSO2, hemoglobin and hematocrit concentration, lactate, hourly urine volume, diuretic requirement, replaced blood and fluid volume, vasoactive agents before induction of anesthesia {1}, directly before skin incision {2}, after sternum detachment {3}, 20 min after aortic cross clamp {4}, 40 min after aortic cross clamp {5}, 20 min after aortic cross clamp removal {6}, 20 min after CPB release {7}, and {8}eight operations will be recorded in time 60 minutes after leaving the CPB. In the postoperative period, daily total balance, diuretic requirement and vasoactive requirement will be recorded 7 days after the operation. Postoperative complications of the patients, length of stay in the intensive care unit, duration of mechanical ventilation, 28-day mortality will be recorded. The incidence of acute kidney injury will be compared between the patients in Group I and Group II according to the criteria of the Global Result of Improvement of Kidney Disease (KDIGO) criteria and postoperative cystatin C levels during the intraoperative and postoperative period.
- Conditions
- Kidney Injury, Acute
- Being tested
- BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?
- Keywords
- Open Heart Surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?Other
In open heart surgery, it will be followed whether acute kidney injury will develop by looking at the biomarkers in the preoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group I | At least two of the preoperative biomarkers (Mg<0.85 mmol/L, Hgb<8.5 mmol/L, proBNP>480 pg/mL, CRP>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, Receives: Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD? | |
| Group II | Patients who meet at least two of the preoperative biomarkers (Mg>0.85 mmol/L, Hgb>8.5 mmol/L, proBNP<480 pg/mL, CRP<5 mg/L) Group II . Receives: Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD? |
What is being measured
The primary outcome is the main question the study is designed to answer.
The requirement of continue venovenous hemodiafiltration (CVVHDF)
After on pump surgery resulting AKI may require CVVHDF(pH<7.21, urine output < 0.5 ml/kg during 6 hours, potassium > 6 mEq/L)
Measured: Immediately after surgery
Predict acute renal failure in on-pomp conary artery bypass via preoperative biomarkers
To detect acute kidney injury in the early period in open heart surgery and to take precautions
Measured: up to postoperative 28th day
Secondary outcomes (1)
The requirement of hemodialysis during postoperative 28 days
After discharging AKI will occur any time line of postoperative period ((pH<7.21, urine output < 0.5 ml/kg,potassium >6 mEq/l)
Measured: up to postoperative 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start30 Sep 2022
- Primary completion30 Nov 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Injury, AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Yücel,MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Gülsüm Oya HERGÜNSEL, Ass. Prof., Study chair, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426291
- Sponsor's protocol ID
- SadiKonuk
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen PC, Hsu YL, Wu LS, Liu XL, Tsai HJ, Wang JY; DISCOVER Study Group. Pediatric post-acute sequelae of SARS-CoV-2 infection in Taiwan: Insights from the DISCOVER cohort. Pediatr Neonatol. 2026 Jul;67(4):343-349. doi: 10.1016/j.pedneo.2026.03.007. Epub 2026 May 29.
PubMed 42285845
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is It Possible to Predict Acute Kidney Damage in Patients Undergoing Open Heart Surgery in the Preoperative Period?
- ClinicalTrials.gov ID
- NCT05426291
- Acronym / sponsor ID
- SadiKonuk
- Conditions
- Kidney Injury, Acute
- Keywords
- Open Heart Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 21 Jun 2022 (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.
Aimed to determine whether preoperative biomarkers (Mg, Hgb, CRP, ProBNP) would be helpful in the early diagnosis of CSA-AKI (cardiac surgery-related acute kidney injury) in patients undergoing open heart surgery.
Detailed description
An adult patient (aged ≥40 years) with ASA II-IV who was scheduled for elective open heart surgery under cardiopulmonary bypass (CPB) in our clinic between March 1, 2022 and October 30, 2022 will be prospectively included in this study. Patients included in the study will be divided into two groups. At least two of the preoperative biomarkers (Mg<0.85 mmol/L, Hgb<8.5 mmol/L, proBNP>480 pg/mL, CRP>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, patients who meet at least two of the preoperative biomarkers (Mg>0.85 mmol/L, Hgb>8.5 mmol/L, proBNP<480 pg/mL, CRP<5 mg/L) Group II will be included in the study.Standard monitoring such as electrocardiogram, non-invasive blood pressure and pulsoximetric saturation (SpO2), cerebral oximetry (bSO2, NIRS) will be performed in all open heart surgery patients. To prevent possible kidney damage, colloid fluids and mannitol will not be used as prime solution and replacement fluid in both groups. As in routine open heart surgery, mean arterial pressure (MAP) will be allowed to vary between 55 and 70 mmHg, the volume deficit will be replaced with erythrocyte suspension and/or crystalloid replacement in the form of 500 ml boluses, keeping the hematocrit above 25%. In case of need for a vasoactive agent, dopamine and/or adrenaline infusion is started in the standard open heart surgery procedure. After the operation, the patients are transferred to the cardiovascular surgery intensive care unit (ICU) under the effect of orotracheal intubation and conscious anesthesia. Demographic characteristics of patients (age, gender, height, weight, body mass index, diabetes mellitus, hypertension, peripheral vascular disease, smoking history, hyperlipidemia, atrial fibrillation history, left ventricular ejection fraction) European Cardiac Operative Risk Assessment System (EuroSCORE), baseline bSo2, preoperative magnesium, proBNP, CRP, hemoglobin, serum urea, creatinine value and calculated glomerular filtration rate, cystatin C value, diagnosis, surgical procedure, cardiopulmonary bypass time and cross clamp time will be recorded. Patients with high preoperative Cystatin C levels will be excluded from the study.Serum urea, creatinine concentration and GFR values will be evaluated and recorded at admission to the hospital, one day before surgery, admission to the intensive care unit, and in the mornings of the following 7 days. Cystatin C concentration will be evaluated and recorded the day before surgery, on the first postoperative day (24 hours after surgery).Heart apex, mean arterial pressure, Spo2, bSO2, hemoglobin and hematocrit concentration, lactate, hourly urine volume, diuretic requirement, replaced blood and fluid volume, vasoactive agents before induction of anesthesia {1}, directly before skin incision {2}, after sternum detachment {3}, 20 min after aortic cross clamp {4}, 40 min after aortic cross clamp {5}, 20 min after aortic cross clamp removal {6}, 20 min after CPB release {7}, and {8}eight operations will be recorded in time 60 minutes after leaving the CPB. In the postoperative period, daily total balance, diuretic requirement and vasoactive requirement will be recorded 7 days after the operation. Postoperative complications of the patients, length of stay in the intensive care unit, duration of mechanical ventilation, 28-day mortality will be recorded. The incidence of acute kidney injury will be compared between the patients in Group I and Group II according to the criteria of the Global Result of Improvement of Kidney Disease (KDIGO) criteria and postoperative cystatin C levels during the intraoperative and postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?At least two of the preoperative biomarkers (Mg<0.85 mmol/L, Hgb<8.5 mmol/L, proBNP>480 pg/mL, CRP>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, |
| Group II | – | Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?Patients who meet at least two of the preoperative biomarkers (Mg>0.85 mmol/L, Hgb>8.5 mmol/L, proBNP<480 pg/mL, CRP<5 mg/L) Group II . |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged ≥40 years,<85 years) with ASA II-IV who were scheduled for elective open heart surgery under cardiopulmonary bypass (CPB) will be prospectively included in this study. Patients included in the study will be divided into two groups. At least two of the preoperative biomarkers (Mg<0.85 mmol/L, Hgb<8.5 mmol/L, proBNP>480 pg/mL, CRP>5 mg/L) that are thought to be closely related to acute kidney injury after cardiac surgery Group I, patients who meet at least two of the preoperative biomarkers (Mg>0.85 mmol/L, Hgb>8.5 mmol/L, proBNP<480 pg/mL, CRP<5 mg/L) Group II will be included in the study.
Key inclusion criteria (1 listed)
- Elective on-pomp coronary artery bypass
Key exclusion criteria (7 listed)
- Emergency operation,
- Off pump coronary artery bypass
- Revision (repetitive) operation
- Preoperative acute Renal failure
- Preoperative chronic Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?In open heart surgery, it will be followed whether acute kidney injury will develop by looking at the biomarkers in the preoperative period. | Other | Group I, Group II |
Primary outcome
The requirement of continue venovenous hemodiafiltration (CVVHDF)
Time frame: Immediately after surgery
After on pump surgery resulting AKI may require CVVHDF(pH<7.21, urine output < 0.5 ml/kg during 6 hours, potassium > 6 mEq/L)
Predict acute renal failure in on-pomp conary artery bypass via preoperative biomarkers
Time frame: up to postoperative 28th day
To detect acute kidney injury in the early period in open heart surgery and to take precautions
1 secondary outcome
The requirement of hemodialysis during postoperative 28 days
Time frame: up to postoperative 28th day
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 17 Jun 2024.
- Derived from this study: PubMed 42285845Chen PC, Hsu YL, Wu LS, Liu XL, Tsai HJ, Wang JY; DISCOVER Study Group. Pediatric post-acute sequelae of SARS-CoV-2 infection in Taiwan: Insights from the DISCOVER cohort. Pediatr Neonatol. 2026 Jul;67(4):343-349. doi: 10.1016/j.pedneo.2026.03.007. Epub 2026 May 29.
- Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort StudyLink provided by the sponsor.
- Postoperative kidney oxygen saturation as a novel marker for acute kidney injury after adult cardiac surgeryLink provided by the sponsor.
- 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.
Gülsüm Oya HERGÜNSEL, Ass. Prof. study chair
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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 Kidney Injury, Acute, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 1 inclusion and 7 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 17 Jun 2024. 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?
The requirement of continue venovenous hemodiafiltration (CVVHDF) (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426291, which also lists 1 linked publication.
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 17 Jun 2024.