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The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.than collect the data of ScvO2 and Pcv-aCO2:

ScvO2≥70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and "\>6mmHg"

The patients with ScvO2 \<70% will receive the standardized fluid therapy for 6 hours.than collect the data of ScvO2 and Pcv-aCO2:

ScvO2\<70%，and furthermore, Pcv-aCO2 is divided into "≤6mmHg" and "\>6mmHg"

The patients with ScvO2 \<70% will receive the standardized fluid therapy for 6 hours.

standardized fluid therapy

The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.

conventional fluid therapy

Yang Yang, physician

Yang Lu, physician

Wanhua Wang, director

This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect of these patients.

1. Confirmed that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic efficacy of this kind of patients.
2. Pcv-aCO2 effectively reflected the improvement of tissue and organ microcirculation disorder through the individual goal target treatment to guide the fluid resuscitation in the hemodynamic instability patients.
3. Research of the correlation between Pcv-aCO2 and the organ function in patients with abnormal hemodynamics after operation.

Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery

Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer

The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

The change of blood lactic acid (Lac, mmol/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

The change of Cardiac Index (CI, L/(min•m\^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Collect the index of oxygen supply (DO2, ml/(min•m\^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Collect the index of oxygen consumption (VO2, ml/(min•m\^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Collect the index of treatment success rate(%) of patients in different groups.

Collect the index of 28 day mortality(%) of patients in different groups.

Collect the index of hospitalization course(days) of patients in different groups.

Tianjin Medical University Cancer Institute and Hospital

Postoperative Complications

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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.

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.

Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.

Applying goal-directed fluid therapy by continuous hemodynamic monitoring system

Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.

Conventional fluid therapy

Yuguang Huang, MD

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.

Goal-directed Intraoperative Fluid Therapy in High-risk Surgery

Effect of Goal-Directed Intraoperative Fluid Therapy on Outcomes Following Laparotomy of Gynecological Malignancies and Orthopedic 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）

the length of stay in hospital，from the hospitalized date to the leave date

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery	NCT02977429	Abdominal Tumor Abdominal Infec...	standardized fl... conventional fl...	18 Years - 65 Years	Tianjin Medical University Cancer Institute and Hospital
Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery	NCT02977429	Abdominal Tumor Abdominal Infec...	standardized fl... conventional fl...	18 Years - 65 Years	Tianjin Medical University Cancer Institute and Hospital
Goal-directed Intraoperative Fluid Therapy in High-risk Surgery	NCT02470221	Postoperative C... Fluid Overload	Applying goal-d... Conventional fl...	18 Years - 90 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for conventional fluid therapy