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This study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost.
This is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. The details are described as follow.
The study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in Peking Union Medical College Hospital. The study included two stages.
In the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. All the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. Specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. It is a standard procedure in Peking Union Medical College Hospital. Then, the incidence of postoperative complications of each group will be recorded. In addition, sample size will be estimated based on above study's results (estimated 100 participants).
In the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. Specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. The incidence of postoperative complications of each group will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-directed fluid therapy | The fluid in group Goal-directed fluid therapy will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the Flo-Trac monitoring system. |
| |
| Conventional fluid therapy | The fluid in group Conventional fluid therapy will be administered based on the principle crystalloid solution: colloid solution =2-3:1. The total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Applying goal-directed fluid therapy by continuous hemodynamic monitoring system | Other | Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative complications | the incidence of complications related to surgeries 30 days postoperatively. The complications include pneumonia, pulmonary embolism, cardiovascular events (myocardial infarction, heart failure), wound infection, gastrointestinal bleeding,nausea and vomitting,postoperative hemorrhage, ileus, deep venous thrombosis, cerebral infarction, cerebral embolism, cerebral hemorrhage, renal insufficiency and failure. Those complications are defined strictly to the reference published in 2009 New England Journal of Medicine (N Engl J Med. 2009 Oct 1;361:1368-75) | 30 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| hospital length of stay | the length of stay in hospital,from the hospitalized date to the leave date | participants will be followed for the duration of hospital stay, an expected average of 10 days |
| hospital expenses |
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Inclusion Criteria:
Exclusion Criteria:
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Patients underwent either laparotomy of gynecological malignancies or orthopedic surgery
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| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang, MD | Peking Union Medical College Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21624138 | Background | Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30. | |
| 21610051 | Background | Kuper M, Gold SJ, Callow C, Quraishi T, King S, Mulreany A, Bianchi M, Conway DH. Intraoperative fluid management guided by oesophageal Doppler monitoring. BMJ. 2011 May 24;342:d3016. doi: 10.1136/bmj.d3016. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D004487 | Edema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| Conventional fluid therapy | Other | Applying conventional fluid therapy according to Peking Union Medical College Hospital standard. |
|
total cost in hospital
| 30 days after the surgery |
| 22626878 | Background | Wang P, Wang HW, Zhong TD. Effect of stroke volume variability- guided intraoperative fluid restriction on gastrointestinal functional recovery. Hepatogastroenterology. 2012 Nov-Dec;59(120):2457-60. doi: 10.5754/hge12283. |
| 23264068 | Background | Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22. |
| 17925428 | Background | Donati A, Loggi S, Preiser JC, Orsetti G, Munch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. doi: 10.1378/chest.07-0621. Epub 2007 Oct 9. |
| 32698766 | Derived | Che L, Zhang XH, Li X, Zhang YL, Xu L, Huang YG. Outcome impact of individualized fluid management during spine surgery: a before-after prospective comparison study. BMC Anesthesiol. 2020 Jul 22;20(1):181. doi: 10.1186/s12871-020-01092-w. |