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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02977429
Enrollment
150
Registered
2016-11-30
Start date
2016-10-31
Completion date
2018-09-30
Last updated
2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Tumor, Abdominal Infection

Keywords

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

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.

Interventions

OTHERstandardized fluid therapy

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

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

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The change of Pcv-aCO2fluid resuscitation for 6 hours, 12 hours and 24 hoursThe change of Pcv-aCO2 (mmHg) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Secondary

MeasureTime frameDescription
The hospitalization course in different groupsTwenty-eighth days after admissionCollect the index of hospitalization course(days) of patients in different groups.
The treatment success rate in different groupsTwenty-eighth days after admissionCollect the index of treatment success rate(%) of patients in different groups.
The 28 day mortality in different groupsTwenty-eighth days after admissionCollect the index of 28 day mortality(%) of patients in different groups.

Other

MeasureTime frameDescription
The Oxygen Supply status (DO2) in different groupsfluid resuscitation for 6 hours, 12 hours and 24 hoursCollect the index of oxygen supply (DO2, ml/(min•m\^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
The change of Central Venous Oxygen Saturation (ScvO2)fluid resuscitation for 6 hours, 12 hours and 24 hoursThe change of Central venous oxygen saturation (ScvO2, %)after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
The Oxygen Consumption (VO2) in different groupsfluid resuscitation for 6 hours, 12 hours and 24 hoursCollect the index of oxygen consumption (VO2, ml/(min•m\^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.
The change of hemoglobin (Hb)fluid resuscitation for 6 hours, 12 hours and 24 hoursThe 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)fluid resuscitation for 6 hours, 12 hours and 24 hoursThe 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)fluid resuscitation for 6 hours, 12 hours and 24 hoursThe change of Cardiac Index (CI, L/(min•m\^2)) after fluid resuscitation for 6 hours, 12 hours and 24 hours respectively.

Countries

China

Contacts

Primary ContactYang Yang, physician
yyicu3021@126.com022-23340123
Backup ContactYang Lu, physician
Yang_lu1299@hotmail.com022-23340123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026