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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02977429
• Other study ID #: bc2016032
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2016
• Last updated: November 27, 2016
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: October 2016
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Yang Yang, physician
• Phone: 022-23340123
• Email: yyicu3021[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Infection
• Abdominal Neoplasms
• Abdominal Tumor
• Intraabdominal Infections

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

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