Goal-directed Intraoperative Fluid Therapy in High-risk Surgery
|ClinicalTrials.gov Identifier: NCT02470221|
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : May 31, 2019
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.
|Condition or disease||Intervention/treatment|
|Postoperative Complications Fluid Overload||Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system Other: Conventional fluid therapy|
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.
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic Surgery|
|Actual Study Start Date :||March 1, 2016|
|Actual Primary Completion Date :||February 10, 2018|
|Actual Study Completion Date :||July 1, 2018|
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.
Other: Applying goal-directed fluid therapy by continuous hemodynamic monitoring system
Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
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.
Other: Conventional fluid therapy
Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.
- postoperative complications [ Time Frame: 30 days after the surgery ]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）
- hospital length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days ]the length of stay in hospital，from the hospitalized date to the leave date
- hospital expenses [ Time Frame: 30 days after the surgery ]total cost in hospital
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470221
|Study Chair:||Yuguang Huang, MD||Peking Union Medical College Hospital|