Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery
2016年11月27日 更新者：Tianjin Medical University Cancer Institute and Hospital
Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer
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.
研究概览
详细说明
- 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.
研究类型
介入性
注册 (预期的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tianjin
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Tianjin、Tianjin、中国、300060
- 招聘中
- Tianjin Medical University Cancer Institute and Hospital
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接触：
- Wanhua Wang, director
- 电话号码：1021 23340123
- 邮箱：Wanhua_Wang1962@outlook.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：standard group
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 conventional fluid therapy.
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假比较器：control group
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The change of Pcv-aCO2
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The treatment success rate in different groups
大体时间：Twenty-eighth days after admission
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Collect the index of treatment success rate(%) of patients in different groups.
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Twenty-eighth days after admission
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The 28 day mortality in different groups
大体时间：Twenty-eighth days after admission
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Collect the index of 28 day mortality(%) of patients in different groups.
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Twenty-eighth days after admission
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The hospitalization course in different groups
大体时间：Twenty-eighth days after admission
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Collect the index of hospitalization course(days) of patients in different groups.
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Twenty-eighth days after admission
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The change of Central Venous Oxygen Saturation (ScvO2)
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of hemoglobin (Hb)
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of blood lactic acid (Lac)
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of blood lactic acid (Lac, mmol/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of Cardiac Index (CI)
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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The change of Cardiac Index (CI, L/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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The Oxygen Supply status (DO2) in different groups
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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Collect the index of oxygen supply (DO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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The Oxygen Consumption (VO2) in different groups
大体时间：fluid resuscitation for 6 hours, 12 hours and 24 hours
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Collect the index of oxygen consumption (VO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
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fluid resuscitation for 6 hours, 12 hours and 24 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Wanhua Wang, director、Tianjin Medical University Cancer Institute and Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
- Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O(2) saturation and venous-to-arterial CO(2) difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.
- Pope JV, Jones AE, Gaieski DF, Arnold RC, Trzeciak S, Shapiro NI; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of central venous oxygen saturation (ScvO(2)) as a predictor of mortality in patients with sepsis. Ann Emerg Med. 2010 Jan;55(1):40-46.e1. doi: 10.1016/j.annemergmed.2009.08.014. Epub 2009 Oct 25.
- Harilall Y, Adam JK, Biccard BM, Reddi A. Correlation between cerebral tissue and central venous oxygen saturation during off-pump coronary bypass graft surgery. Perfusion. 2011 Mar;26(2):83-90. doi: 10.1177/0267659110387846. Epub 2010 Nov 15.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年10月1日
初级完成 (预期的)
2018年1月1日
研究完成 (预期的)
2018年9月1日
研究注册日期
首次提交
2016年10月9日
首先提交符合 QC 标准的
2016年11月27日
首次发布 (估计)
2016年11月30日
研究记录更新
最后更新发布 (估计)
2016年11月30日
上次提交的符合 QC 标准的更新
2016年11月27日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
conventional fluid therapy的临床试验
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University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI); National Institute of Nursing Research (NINR)完全的
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的