NCT02977429Unknown不适用
Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The change of Pcv-aCO2
研究概览
简要总结
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.
详细描述
- 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.
- 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.
- Research of the correlation between Pcv-aCO2 and the organ function in patients with abnormal hemodynamics after operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute physiology and chronic health score system II (APACHE II) score ≥10；
- •Hemodynamic abnormalities post-operation (a. systolic blood pressure<90mmHg, or descent by basic blood pressure for more than 40mmHg. b. pulse pressure <20mmHg, c. urine volume <0.5ml/Kg/hr, d. heart rate >100 / min, e.Central Venous Pressure(CVP) <5mmHg, f. blood lactic acid >2.7mmol/L, meet any one above).
- •Age ≥ 18 years, which is expected to stay in ICU for 5 days or longer;
- •Patients themselves or their authorized clients agree to participate in clinical trials and signed informed consent.
排除标准
- •age <18 years;
- •without improvement in respiratory system disease or chronic obstructive pulmonary disease with Forced expiratory volume in one second (FEV1) <50%;
- •lobectomy and pneumonectomy;
- •death within 24 after treatment;
- •patients with severe organ dysfunction;
- •pregnant or lactating women;
- •the patients did not sign informed consent;
- •any factors that may be expected to increase the risk of patients or other factors that may interfere with the results of clinical trials.
结局指标
主要结局
The change of Pcv-aCO2
时间窗: fluid resuscitation for 6 hours, 12 hours and 24 hours
The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
次要结局
- The 28 day mortality in different groups(Twenty-eighth days after admission)
- The hospitalization course in different groups(Twenty-eighth days after admission)
- The treatment success rate in different groups(Twenty-eighth days after admission)
研究者
研究点 (1)
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