Effects of Goal-directed Fluid Therapy and Restrictive Fluid Therapy During Operation Combined With Enhanced Recovery After Surgery Protocol on Acute Kidney Injury After Thoracoscopic Lobectomy in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- number of participants with acute kidney injury
研究概览
简要总结
Background: Acute kidney injury (AKI) often occurs after thoracoscopic lobectomy in high risk patients. Insufficient intraoperative infusion is risk factor of AKI. Goal-directed fluid therapy (GDFT) is individualized fluid infusion strategy, the infusion rate and type is adjusted according to the individual's fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) integrates a range of perioperative interventions to decrease postoperative complications after surgery. In ERAS protocol of lobectomy, restrictive fluid therapy during operation is recommended. In this study, the investigators will compare the effects of GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients.
Methods/design: This is prospective single-center single-blind randomized controlled trial. 276 patients scheduled to undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block are randomly divided into GDFT group and restrictive fluid therapy group at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes are (1) the incidence of renal replacement therapy, (2) length of intensive care unit (ICU) stay after operation, (3) length of hospital stay after operation , (4) incidence of other complications including: infection, acute lung injury (ALI), pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery (MINS), cardiac infarction.
Discussion: This is the first study to compare GDFT and restrictive fluid therapy during operation combined with ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high risk patients. The investigators expected that the two methods have the same effect on the incidence of AKI, but restrictive fluid therapy is simpler to applied than GDFT.
详细描述
Participants: Patients aged more than 18 years old who are scheduled to undergo thoracoscopic lobectomy well be enrolled in this trial. Participants will be randomly allocated to one of the two groups: (1) GDFT group and (2) restrictive fluid therapy group. Participants will be allocated in a 1:1 ratio using random numbers generated by Microsoft Excel.
Interventions: All participants will start lung function exercise, quit smoking, reinforce nutrition after hospitalization. Participants will fast for 6 hours and prohibit of drinking water for 2 hours before operation. Antibiotic will be used 1 hour before operation. No premedication will be administered to the patients. The electrocardiography (ECG), pulse oximetry, invasive arterial blood pressure, nasopharyngeal temperature, and bispectral index monitoring will be instituted. Urinary catheter will be inserted after anesthesia and removed immediately after operation. Patients will undergo thoracoscopic lobectomy under general anesthesia combined with paravertebral block. General anesthesia will be inducted with sufentanil, propofol, and rocuronium, and maintained with continuous infusion of propofol and remifentanil, intermittent injection of rocuronium. Lung-protective ventilation strategy will be used during mechanical ventilation. Recovery from general anesthesia as quickly as possible. Paravertebral block will be performed under the guidance of ultrasound after general anesthesia induction. Paravertebral block, patient controlled analgesia and oral analgesics will be used for postoperative analgesia. Recovering of oral rehydration, eating and getting out of bed as early as possible.
In GDFT group, the arterial catheter will be connected with FloTrac/Vigileo sensor (Edwards lifesciences, Irvine, CA, USA), The stroke volume variation (SVV) and cardiac index (CI) will be monitored. Fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, when SVV>13%, 4 mL/kg bolus of hydroxyethyl starch will be infused within 5 min. If SVV falls below 13%, the bolus will be suspended. If SVV is still more than 13%, 100 μg of phenylephrine will be administered when CI is more than 2.5 L/min/m2, 1 mg of dopamine will be administered when CI is less than 2.5 L/min/m2. When SVV<13%, but mean arterial pressure (MAP)<65 mmHg, 8 μg of norepinephrine will be administered. The hemodynamic status will be repeatedly measured every 10 min.
In restrictive fluid therapy group, fluid maintenance with 2 ml/kg/h of Ringer's solution of sodium acetate, hydroxyethyl starch will be infused to supply blood loss, the ratio of hydroxyethyl starch to blood loss is 1:1. 0.01-0.1 μg/kg/min of norepinephrine will be administered to maintain MAP>65 mmHg.
Measurements: The primary outcome is the incidence of AKI after operation. The secondary outcomes include: (1) Incidence of renal replacement therapy, (2) Length of ICU stay after operation, (3) Length of hospital stay after operation, (4) Incidence of other complications including: infection, ALI, pneumonia, arrhythmia, heart failure, MINS, cardiac infarction.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Allocations will be blinded to all participants but the anesthesiologists. If serious adverse events occur, the patients will be removed from the trial, the blinding will be removed, the events will be reported to the institutional review board.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients comply any of the following criteria will be enrolled
- •Age>70 years old
- •Forced expiratory volume in 1 second (FEV1)<60%
- •Carbon monoxide lung diffusion capacity (DLCO)<60%
- •History of coronary artery disease
排除标准
- •patients comply any of the following criteria may not be enrolled
- •Patients refused
- •Creatinine>176 μmol/L, and/or BUN>7.1 mmol/L
- •NT-proBNP>300 ng/L
- •Systemic or local infection
- •Albumin<30 g/L, and/or Hemoglobin<100 g/L
- •Allergy to hydroxyethyl starch
结局指标
主要结局
number of participants with acute kidney injury
时间窗: 48 hours after operation
50% relative or 0.3 mg/dl (26.5 μmol/L) absolute increase in creatinine over the preoperative value during the first two postoperative days.
次要结局
- length of ICU stay after operation(30 days after operation)
- number of participants with myocardial injury after noncardiac surgery(7 days after operation)
- number of participants in need of renal replacement therapy(30 days after operation)
- length of hospital stay after operation(30 days after operation)
- number of participants with infection(30 days after operation)
- number of participants with pneumonia(30 days after operation)
- number of participants with arrhythmia(48 hours after operation)
- number of participants with acute lung injury(24 hours after operation)
- number of participants with heart failure(48 hours after operation)
- number of participants with cardiac infarction(48 hours after operation)
