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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Abdominal Tumor, Abdominal Infection

Intervention / Treatment
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* Other: standardized fluid therapy
* Other: conventional fluid therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard group<br>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 | Other: conventional fluid therapy<br>* The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.<br>|
| Sham Comparator: control group<br>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 | Other: standardized fluid therapy<br>* The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.<br>* Other names: Therapeutic effect of fluid resuscitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Pcv-aCO2 | The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The treatment success rate in different groups | Collect the index of treatment success rate(%) of patients in different groups. | Twenty-eighth days after admission | 
| The 28 day mortality in different groups | Collect the index of 28 day mortality(%) of patients in different groups. | Twenty-eighth days after admission | 
| The hospitalization course in different groups | Collect the index of hospitalization course(days) of patients in different groups. | Twenty-eighth days after admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal infection, Tumor, Hemodynamics, Pcv-aCO2, Early Goal-directed Therapy (EGDT)