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临床试验/NCT06378827
NCT06378827招募中2 期

The Effect of Intraoperative Dexmedetomidine on Renal Function After Coronary Artery Bypass Graft Surgery

University of Novi Sad1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
100
试验地点
1
主要终点
Indicator of renal function

研究概览

简要总结

This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery.

详细描述

This study will include patients admitted to the Clinic for Cardiovascular Surgery of the Institute of Cardiovascular Diseases of Vojvodina, planned for elective coronary artery bypass graft surgery (CABG). Basic demographic and anthropometric data (gender, age, height, weight, and body mass index) and data on comorbidities, therapy, and allergies will be recorded. The day before surgery, all patients will undergo transthoracic echocardiography, on the basis of which the ejection fraction of the left ventricle will be determined and recorded. After the entire examination, the New York Heart Association (NYHA) class, American Society of Anaesthesiologists physical status (ASA score), and Estimate risk of in-hospital death after cardiac surgery score (EuroSCORE II) will be determined. The method and purpose of the research will be explained to all patients, after which informed consent for participation in the research will be obtained.

The patients will be divided into two groups (experimental and control) using the randomization method. All patients will have blood drawn for laboratory and biochemical analyses the morning before surgery: urea, creatinine, cystatin C, IL-6, hemoglobin, leukocytes, platelets, glycemia, aspartate aminotransferase (AST), alanine transaminase (ALT), lactate dehydrogenase (LDH), direct and total bilirubin, fibrinogen, CRP, CK-MB, hS troponin I, electrolytes (Na+ and K+), and lactates. With the help of the Cockcroft-Gault formula, the estimated glomerular filtration rate (eGFR) and creatinine clearance (CCr) will be determined. The values of all these analyses will be defined as basal values.

The anesthetic and surgical protocol, as well as the postoperative treatment, will be standardized. Half an hour before arriving in the operating room, patients will receive about 0.05 mg/kg of midazolam per os as premedication. Upon arrival in the operating room, electrodes for continuous monitoring of the electrocardiogram (ECG), electrodes for assessing the depth of anesthesia, and pulse oximetry for monitoring pulse saturation (SpO2) will be attached to all patients. Anesthetist nurses will place a peripheral venous cannula, usually in one of the veins of the right arm, through which infusion solutions will be applied in the perioperative period and if necessary, transfusions of autologous blood, resuspended erythrocytes, platelets, and fresh frozen plasma. The anesthesiologist will place the arterial cannula, mostly in the left radial artery, for continuous monitoring of arterial blood pressure values. After adequate preoxygenation (8 l/min, 3 min) via a ventilation mask, the intravenous anesthesia will be administered with a combination of the benzodiazepine midazolam (about 0.05 mg/kg), the opioid analgesic sufentanil (about 0.15 µg/kg), intravenous anesthetic propofol (about 1 mg/kg), and the neuromuscular relaxant rocuronium bromide (about 0.8 mg/kg). After endotracheal intubation, patients will be on mechanical lung ventilation (MLV) - volume-controlled ventilation mode with a tidal volume of 6-8 ml/kg of ideal body weight, a respiratory rate of 12/min, FiO2 of 0.5, a positive end-expiratory pressure (PEEP) of 5 cmH2O, and an inspiratory ratio to expirium - I:E 1:2. The flow of fresh gases at the MLV in all patients will be 3 l/min. Correction of MLV parameters will be done based on partial pressures of oxygen (PaO2) and carbon dioxide (PaCO2) in arterial blood, with the aim of maintaining PaO2 >100 mmHg and PaCO2 35-45 mmHg. A three-lumen central venous catheter (CVC) will be placed mainly in the right interior jugular vein. All patients will be placed with a urinary catheter to monitor hourly diuresis as well as a nasopharyngeal probe to monitor nasopharyngeal temperature.

Dexmedetomidine solution will be prepared by diluting one ampoule of dexmedetomidine (200µg/2ml) with 48 ml of saline solution to obtain a dexmedetomidine solution of 4µg/ml. Patients from the experimental group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 µg/kg/h, until the end of the operation. Patients in the control group will receive the same volume of saline solution.

Anesthesia will be maintained with the inhaled anesthetic sevoflurane, with target depth of anesthesia values between 40 and 60, as measured by entropy. A continuous intravenous infusion of sufentanil (0.5-1 µg/kg/h) will be used for intraoperative analgesia. Neuromuscular relaxation will be maintained by intermittent bolus doses of rocuronium bromide (on average, about 0.4 mg/kg/h). All patients will receive an intravenous antibiotic (Ceftriaxone 1g) half an hour before the surgical incision, and in cases of allergy to cephalosporins, Vancomycin 500 mg. All patients are prescribed tranexamic acid according to the protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective coronary artery bypass graft surgery
  • Age over 18 years
  • ASA score 3 or 4
  • Voluntary consent of the patient to participate in the research

排除标准

  • Emergency coronary artery bypass graft surgery
  • Chronic renal failure with eGFR <60 ml/min/1.73m2
  • Left ventricular ejection fraction <30%
  • 2nd or 3rd degree atrioventricular block
  • Use of nephrotoxic agents such as aminoglycoside antibiotics or contrast agents within the last 48 hours
  • Previous heart surgery or kidney surgery
  • Allergy to dexmedetomidine

研究组 & 干预措施

Experimental

Experimental

Patients from the experimental group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 µg/kg/h, until the end of the operation.

干预措施: Dexmedetomidine (Drug)

Control

Placebo Comparator

Patients in the control group will receive the same volume of saline solution.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Indicator of renal function

时间窗: 5 days

The primary objective of the study will be to monitor serum creatinine (µmol/L) and compare between groups. The changes of all these values in relation to the basal values will be monitored in order to determine when the greatest changes in the serum creatinine values occur.

An early biomarker of kidney injury

时间窗: 2 days

The primary objective of the study will be to monitor serum cystatin C (mg/L) and compare between groups. The changes of all these values in relation to the basal values will be monitored in order to determine when the greatest changes in the serum cystatin C values occur.

The change of inflammatory markers

时间窗: 24 hours

The change of inflammatory marker IL-6 (pg/mL) in relation to basal values is also one of the primary goals of the research. IL-6 will be checked on the first postoperative day, when the inflammatory response is most pronounced.

次要结局

  • Length of postoperative mechanical ventilation(24 hours)
  • Length of stay in the intensive care unit(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ranko Zdravkovic

Principal Investigator

University of Novi Sad

研究点 (1)

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