Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial
Abstract Background Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid infusion strategy; the fluid infusion strategy is adjusted according t...
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| Format: | Article |
| Language: | English |
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BMC
2021-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-020-04983-y |
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| author | Zheng Guan Yanfeng Gao Qiao Qiao Qiang Wang Jingjie Liu |
| author_facet | Zheng Guan Yanfeng Gao Qiao Qiao Qiang Wang Jingjie Liu |
| author_sort | Zheng Guan |
| collection | DOAJ |
| description | Abstract Background Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid infusion strategy; the fluid infusion strategy is adjusted according to the patient’s fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) protocol optimizes perioperative interventions to decrease the postoperative complications after surgery. In ERAS protocol of lobectomy, intraoperative restrictive fluid therapy is recommended. In this study, we will compare the effects of intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients. Methods/design This is a prospective single-center single-blind randomized controlled trial. Two hundred seventy-six patients scheduled for thoracoscopic lobectomy are randomly allocated to receive either GDFT or restrictive fluid therapy combined with an ERAS protocol at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes include (1) the incidence of renal replacement therapy, (2) the length of intensive care unit stay after operation, (3) the length of hospital stay after operation, and (4) the incidence of other complications including infection, acute lung injury, pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery, and cardiac infarction. Discussion This is the first study to compare intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients. The hypothesis is that the restrictive fluid therapy is noninferior to GDFT in reducing the incidence of AKI, but restrictive fluid therapy is simpler to apply than GDFT. Trial registration ClinicalTrials.gov NCT04302467 . Registered on 26 February 2020 |
| first_indexed | 2024-12-24T00:21:46Z |
| format | Article |
| id | doaj.art-536fb986ee0742048c32b1254492033a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-24T00:21:46Z |
| publishDate | 2021-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-536fb986ee0742048c32b1254492033a2022-12-21T17:24:33ZengBMCTrials1745-62152021-01-012211810.1186/s13063-020-04983-yEffects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trialZheng Guan0Yanfeng Gao1Qiao Qiao2Qiang Wang3Jingjie Liu4Department of Anesthesiology, the First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Anesthesiology, the First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Anesthesiology, the First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Anesthesiology, the First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Neurology, the Second Affiliated Hospital of Xi’an Jiaotong UniversityAbstract Background Acute kidney injury (AKI) is a common complication after thoracoscopic lobectomy in high-risk patients due to insufficient intraoperative infusion. Goal-directed fluid therapy (GDFT) is an individualized fluid infusion strategy; the fluid infusion strategy is adjusted according to the patient’s fluid response. GDFT during operation can reduce the incidence of AKI after major surgery. Enhanced recovery after surgery (ERAS) protocol optimizes perioperative interventions to decrease the postoperative complications after surgery. In ERAS protocol of lobectomy, intraoperative restrictive fluid therapy is recommended. In this study, we will compare the effects of intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients. Methods/design This is a prospective single-center single-blind randomized controlled trial. Two hundred seventy-six patients scheduled for thoracoscopic lobectomy are randomly allocated to receive either GDFT or restrictive fluid therapy combined with an ERAS protocol at a 1:1 ratio. The primary outcome is the incidence of AKI after operation. The secondary outcomes include (1) the incidence of renal replacement therapy, (2) the length of intensive care unit stay after operation, (3) the length of hospital stay after operation, and (4) the incidence of other complications including infection, acute lung injury, pneumonia, arrhythmia, heart failure, myocardial injury after noncardiac surgery, and cardiac infarction. Discussion This is the first study to compare intraoperative GDFT with restrictive fluid therapy combined with an ERAS protocol on the incidence of AKI after thoracoscopic lobectomy in high-risk patients. The hypothesis is that the restrictive fluid therapy is noninferior to GDFT in reducing the incidence of AKI, but restrictive fluid therapy is simpler to apply than GDFT. Trial registration ClinicalTrials.gov NCT04302467 . Registered on 26 February 2020https://doi.org/10.1186/s13063-020-04983-yThoracoscopic lobectomyGoal-directed fluid therapyEnhanced recovery after surgeryAcute kidney injuryRandomized controlled trial |
| spellingShingle | Zheng Guan Yanfeng Gao Qiao Qiao Qiang Wang Jingjie Liu Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial Trials Thoracoscopic lobectomy Goal-directed fluid therapy Enhanced recovery after surgery Acute kidney injury Randomized controlled trial |
| title | Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial |
| title_full | Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial |
| title_fullStr | Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial |
| title_full_unstemmed | Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial |
| title_short | Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial |
| title_sort | effects of intraoperative goal directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high risk patients study protocol for a prospective randomized controlled trial |
| topic | Thoracoscopic lobectomy Goal-directed fluid therapy Enhanced recovery after surgery Acute kidney injury Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-020-04983-y |
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