Acute Kidney Damage in Patients Undergoing Open Heart Surgery

Kidney Injury, Acute Clinical Trial

Official title:

Is It Possible to Predict Acute Kidney Damage in Patients Undergoing Open Heart Surgery in the Preoperative Period?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426291
• Other study ID #: SadiKonuk
• Status: Recruiting
• Start date: August 30, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2022
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: TUGBA YÜCEL, Md
• Phone: 05349542445
• Email: tugbayucel09[@]gmail.com
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: November 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Mininum Age : 40Years Maximum Age: 85 Years Sex: All Gender Base: No Accepts Healthy Volunteers:No Criteria:

Inclusion Criteria:

• Elective on-pomp coronary artery bypass

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Injury, Acute

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	BakirkoySadiKonuk Training and Searching Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Immediately after surgery
Primary	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	up to postoperative 28th day
Secondary	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)	up to postoperative 28th day

External Links

•   Associations Between Preoperative Biomarkers and Cardiac Surgery-Associated Acute Kidney Injury in Elderly Patients: A Cohort Study
•   Postoperative kidney oxygen saturation as a novel marker for acute kidney injury after adult cardiac surgery