Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04302467
Brief Summary:
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.
Detailed Description:
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.
Sample size: The primary outcome of this trial is the incidence of AKI after operation. Another study showed that the incidence of AKI was 4% and 2.9% in liberal infusion and GDFT respectively, the efficacy of intervention was 27.5%. Investigators hypothesis that restrictive fluid therapy combined with ERAS protocol has the same therapeutic effect as GDFT. The sample size for this study was calculated to achieve a statistical power of 0.8 and alpha error of 0.05 using a two-sided test. Considering a dropout rate of 10%, 138 patients are required in each group.
Statistical analysis: Normally distributed data will be presented as the mean±standard deviation. Categorical data will be presented as the number and the percentage of patients. The primary outcome (the incidence of AKI after operation) will be compared between the two groups with Pearson's chi-square test. The secondary outcomes will be compared between the two groups with independent-samples Student's t-tests for normally distributed continuous data and Pearson's chi-square test for categorical data. All statistical test are two-sided, and a P-value \<0.05 will be considered statistically significant.
Study:
NCT04302467
Study Brief:
Protocol Section:
NCT04302467