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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05426291
Study groupRoleWhat they receive
Group IAt 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 IIPatients 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.

  1. 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

  2. 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)
  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.

  1. First posted21 Jun 2022
  2. Study start30 Sep 2022
  3. Primary completion30 Nov 2023
  4. Study completion30 May 2024

Resources

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
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

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.

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