- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02977429
Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yang Yang, physician
- Phone Number: 1021 022-23340123
- Email: yyicu3021@126.com
Study Contact Backup
- Name: Yang Lu, physician
- Phone Number: 1021 022-23340123
- Email: Yang_lu1299@hotmail.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
-
Contact:
- Wanhua Wang, director
- Phone Number: 1021 23340123
- Email: Wanhua_Wang1962@outlook.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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" |
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" |
The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Twenty-eighth days after admission
|
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.
|
Twenty-eighth days after admission
|
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.
|
Twenty-eighth days after admission
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
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.
|
fluid resuscitation for 6 hours, 12 hours and 24 hours
|
Collaborators and Investigators
Investigators
- Study Director: Wanhua Wang, director, Tianjin Medical University Cancer Institute and Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bc2016032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Abdominal Infection
-
University of BolognaIRCCS Azienda Ospedaliero-Universitaria di BolognaCompletedIntra-Abdominal InfectionItaly
-
Peking Union Medical College HospitalActive, not recruitingPostoperative Infection | Abdominal Surgery | Intra-abdominal Infection | Postoperative FeverChina
-
PfizerCompletedComplicated Intra-abdominal InfectionJapan
-
Cubist Pharmaceuticals LLCCompletedComplicated Intra-abdominal InfectionUnited States, Argentina, Serbia, Georgia, Russian Federation
-
Wyeth is now a wholly owned subsidiary of PfizerPfizerCompletedComplicated Intra-Abdominal InfectionGreece
-
Merck Sharp & Dohme LLCCompletedComplicated Intra-Abdominal InfectionBrazil, Hungary, United States, Lithuania, Malaysia, Mexico, Romania, Russian Federation, South Africa, Spain, Turkey, Ukraine
-
Merck Sharp & Dohme LLCCompletedIntra-abdominal Infection | Complicated Intra-abdominal Infection
-
Merck Sharp & Dohme LLCCompletedComplicated Intra-abdominal Infection
-
University of Sao Paulo General HospitalCompletedAbdominal Wall Defect | Infection | Abdominal Wall Hernia | Abdominal Wall Fistula | Abdominal Wall InfectionBrazil
Clinical Trials on conventional fluid therapy
-
Rajiv Gandhi Cancer Institute & Research Center...CompletedEnhanced Recovery | Fluid LossIndia
-
Huang YuGuangCompletedPostoperative Complications | Fluid Overload
-
Fundación Pública Andaluza para la gestión de la...CompletedFluid Therapy | Goal Directed TherapySpain
-
Assiut UniversityCompleted
-
Helsinki University Central HospitalCompletedPostoperative Complications
-
National Taiwan University HospitalCompletedPostoperative Cognitive Dysfunction | AnesthesiaTaiwan
-
Cairo UniversityCompletedPost-Dural Puncture HeadacheEgypt
-
ZhiHeng LiuCompletedGoal-directed Fluid TherapyChina
-
National Taiwan University HospitalTerminatedOther Complications of EsophagostomyTaiwan
-
Methodist Health SystemRecruitingAcute PancreatitisUnited States