Clinical trial NCT02977429: Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery
Official title: Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Tumor
Abdominal Infection
Keywords: Tumor
Abdominal infection
Hemodynamics
Pcv-aCO2
Early Goal-directed Therapy (EGDT)
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Acute physiology and chronic health score system II (APACHE II) score ≥10；
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:

1. age \<18 years;
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.

Primary outcomes:
measure: The change of Pcv-aCO2
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
Secondary outcomes:
measure: The treatment success rate in different groups
timeFrame: Twenty-eighth days after admission
measure: The 28 day mortality in different groups
timeFrame: Twenty-eighth days after admission
measure: The hospitalization course in different groups
timeFrame: Twenty-eighth days after admission
Other outcomes:
measure: The change of Central Venous Oxygen Saturation (ScvO2)
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
measure: The change of hemoglobin (Hb)
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
measure: The change of blood lactic acid (Lac)
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
measure: The change of Cardiac Index (CI)
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
measure: The Oxygen Supply status (DO2) in different groups
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
measure: The Oxygen Consumption (VO2) in different groups
timeFrame: fluid resuscitation for 6 hours, 12 hours and 24 hours
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Wanhua Wang, director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.