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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02977429
Recruitment Status : Unknown
Verified October 2016 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment Phase
Abdominal Tumor Abdominal Infection Other: standardized fluid therapy Other: conventional fluid therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Active Comparator: 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"

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

Sham Comparator: 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"

Other: standardized fluid therapy
The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.
Other Name: Therapeutic effect of fluid resuscitation




Primary Outcome Measures :
  1. The change of Pcv-aCO2 [ Time Frame: fluid resuscitation for 6 hours, 12 hours and 24 hours ]
    The change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.


Secondary Outcome Measures :
  1. The treatment success rate in different groups [ Time Frame: Twenty-eighth days after admission ]
    Collect the index of treatment success rate(%) of patients in different groups.

  2. The 28 day mortality in different groups [ Time Frame: Twenty-eighth days after admission ]
    Collect the index of 28 day mortality(%) of patients in different groups.

  3. The hospitalization course in different groups [ Time Frame: Twenty-eighth days after admission ]
    Collect the index of hospitalization course(days) of patients in different groups.


Other Outcome Measures:
  1. The change of Central Venous Oxygen Saturation (ScvO2) [ Time Frame: fluid resuscitation for 6 hours, 12 hours and 24 hours ]
    The change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

  2. The change of hemoglobin (Hb) [ Time Frame: fluid resuscitation for 6 hours, 12 hours and 24 hours ]
    The change of hemoglobin (Hb, g/L) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

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

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

  5. The Oxygen Supply status (DO2) in different groups [ Time Frame: fluid resuscitation for 6 hours, 12 hours and 24 hours ]
    Collect the index of oxygen supply (DO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

  6. The Oxygen Consumption (VO2) in different groups [ Time Frame: fluid resuscitation for 6 hours, 12 hours and 24 hours ]
    Collect the index of oxygen consumption (VO2, ml/(min•m^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977429


Contacts
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Contact: Yang Yang, physician 022-23340123 ext 1021 yyicu3021@126.com
Contact: Yang Lu, physician 022-23340123 ext 1021 Yang_lu1299@hotmail.com

Locations
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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Wanhua Wang, director    23340123 ext 1021    Wanhua_Wang1962@outlook.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Director: Wanhua Wang, director Tianjin Medical University Cancer Institute and Hospital

Publications:
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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02977429    
Other Study ID Numbers: bc2016032
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
Tumor
Abdominal infection
Hemodynamics
Pcv-aCO2
Early Goal-directed Therapy (EGDT)
Additional relevant MeSH terms:
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Intraabdominal Infections
Abdominal Neoplasms
Infection
Neoplasms by Site
Neoplasms