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

Primary Purpose

Abdominal Tumor, Abdominal Infection

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

standardized fluid therapy

conventional fluid therapy

About this trial

This is an interventional treatment trial for Abdominal Tumor focused on measuring Tumor, Abdominal infection, Hemodynamics, Pcv-aCO2, Early Goal-directed Therapy (EGDT)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

standard group

control group

Arm Description

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"

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"

Outcomes

Primary Outcome Measures

The change of Pcv-aCO2

The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Secondary Outcome Measures

The treatment success rate in different groups

Collect the index of treatment success rate(%) of patients in different groups.

The 28 day mortality in different groups

Collect the index of 28 day mortality(%) of patients in different groups.

The hospitalization course in different groups

Collect the index of hospitalization course(days) of patients in different groups.

Full Information

NCT ID

NCT02977429

First Posted

October 9, 2016

Last Updated

November 27, 2016

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02977429

Brief Title

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

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Tumor, Abdominal Infection

Keywords

Tumor, Abdominal infection, Hemodynamics, Pcv-aCO2, Early Goal-directed Therapy (EGDT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

standard group

Arm Type

Active Comparator

Arm Description

Arm Title

control group

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

standardized fluid therapy

Other Intervention Name(s)

Therapeutic effect of fluid resuscitation

Intervention Description

The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.

Intervention Type

Other

Intervention Name(s)

conventional fluid therapy

Intervention Description

The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.

Primary Outcome Measure Information:

Title

The change of Pcv-aCO2

Description

The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

Secondary Outcome Measure Information:

Title

The treatment success rate in different groups

Description

Collect the index of treatment success rate(%) of patients in different groups.

Time Frame

Twenty-eighth days after admission

Title

The 28 day mortality in different groups

Description

Collect the index of 28 day mortality(%) of patients in different groups.

Time Frame

Twenty-eighth days after admission

Title

The hospitalization course in different groups

Description

Collect the index of hospitalization course(days) of patients in different groups.

Time Frame

Twenty-eighth days after admission

Other Pre-specified Outcome Measures:

Title

The change of Central Venous Oxygen Saturation (ScvO2)

Description

The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

Title

The change of hemoglobin (Hb)

Description

The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

Title

The change of blood lactic acid (Lac)

Description

The change of blood lactic acid (Lac, mmol/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

Title

The change of Cardiac Index (CI)

Description

The change of Cardiac Index (CI, L/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

Title

The Oxygen Supply status (DO2) in different groups

Description

Collect the index of oxygen supply (DO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

Title

The Oxygen Consumption (VO2) in different groups

Description

Collect the index of oxygen consumption (VO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Time Frame

fluid resuscitation for 6 hours, 12 hours and 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Yang, physician

Phone

022-23340123

Ext

1021

yyicu3021@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Lu, physician

Phone

022-23340123

Ext

1021

Yang_lu1299@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wanhua Wang, director

Organizational Affiliation

Tianjin Medical University Cancer Institute and Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wanhua Wang, director

Phone

23340123

Ext

1021

Wanhua_Wang1962@outlook.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

21034476

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.

Results Reference

background

PubMed Identifier

20179283

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.

Results Reference

background

PubMed Identifier

19854541

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.

Results Reference

background

PubMed Identifier

21078769

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.

Results Reference

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

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