Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery
NCT ID: NCT02977429
Last Updated: 2016-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2016-10-31
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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"
conventional fluid therapy
The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.
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"
standardized fluid therapy
The patients with ScvO2 \<70% will receive the standardized fluid therapy for 6 hours.
Interventions
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standardized fluid therapy
The patients with ScvO2 \<70% will receive the standardized fluid therapy for 6 hours.
conventional fluid therapy
The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Age ≥ 18 years, which is expected to stay in ICU for 5 days or longer;
4. Patients themselves or their authorized clients agree to participate in clinical trials and signed informed consent.
Exclusion Criteria
2. without improvement in respiratory system disease or chronic obstructive pulmonary disease with Forced expiratory volume in one second (FEV1) \<50%;
3. lobectomy and pneumonectomy;
4. death within 24 after treatment;
5. patients with severe organ dysfunction;
6. pregnant or lactating women;
7. the patients did not sign informed consent;
8. any factors that may be expected to increase the risk of patients or other factors that may interfere with the results of clinical trials.
18 Years
65 Years
ALL
Yes
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Wanhua Wang, director
Role: STUDY_DIRECTOR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wanhua Wang, director
Role: primary
References
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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.
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.
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.
Other Identifiers
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bc2016032
Identifier Type: -
Identifier Source: org_study_id