Acute Kidney Damage in Patients Undergoing Open Heart Surgery

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.

Study Overview

• Status: Completed
• Conditions: Kidney Injury, Acute
• Intervention / Treatment: Other: BIOMARKER LEVELS IS IT POSSIBLE TO PREDICT ACUTE RENAL DAMAGE IN THE PREOP PERIOD?

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 Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34147
    • BakirkoySadiKonuk Training and Searching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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,	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.
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 .	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Study Chair: Gülsüm Oya HERGÜNSEL, Ass. Prof., Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Open Heart Surgery
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: SadiKonuk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No