Abdominal Infection Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O2 saturation and venous-to-arterial CO2 difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The change of Central Venous Oxygen Saturation (ScvO2) | The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | Yes |
Other | The change of hemoglobin (Hb) | The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | Yes |
Other | The change of blood lactic acid (Lac) | The change of blood lactic acid (Lac, mmol/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | Yes |
Other | The change of Cardiac Index (CI) | The change of Cardiac Index (CI, L/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | Yes |
Other | The Oxygen Supply status (DO2) in different groups | Collect the index of oxygen supply (DO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | Yes |
Other | The Oxygen Consumption (VO2) in different groups | Collect the index of oxygen consumption (VO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively. | fluid resuscitation for 6 hours, 12 hours and 24 hours | Yes |
Primary | 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 | Yes |
Secondary | The treatment success rate in different groups | Collect the index of treatment success rate(%) of patients in different groups. | Twenty-eighth days after admission | Yes |
Secondary | The 28 day mortality in different groups | Collect the index of 28 day mortality(%) of patients in different groups. | Twenty-eighth days after admission | Yes |
Secondary | The hospitalization course in different groups | Collect the index of hospitalization course(days) of patients in different groups. | Twenty-eighth days after admission | Yes |
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