Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05426291 |
| Other study ID # |
SadiKonuk |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2022 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Bakirkoy Dr. Sadi Konuk Research and Training Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
