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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

Tracking Information
First Submitted Date  ICMJE October 9, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date November 30, 2016
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2016)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 27, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery
Official Title  ICMJE Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Tumor
  • Abdominal Infection
Intervention  ICMJE
  • 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
  • Other: conventional fluid therapy
    The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.
Study Arms  ICMJE
  • 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"

    Intervention: Other: 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"

    Intervention: Other: standardized fluid therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 27, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02977429
Other Study ID Numbers  ICMJE bc2016032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Tianjin Medical University Cancer Institute and Hospital
Study Sponsor  ICMJE Tianjin Medical University Cancer Institute and Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wanhua Wang, director Tianjin Medical University Cancer Institute and Hospital
PRS Account Tianjin Medical University Cancer Institute and Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP