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

Tianjin Medical University

Status: Unknown

Conditions: Abdominal Infection; Abdominal Tumor

Treatments: Other: conventional fluid therapy; Other: standardized fluid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02977429

bc2016032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

standard group

Active Comparator group

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"

Treatment:

Other: conventional fluid therapy

control group

Sham Comparator group

Description:

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"

Treatment:

Other: standardized fluid therapy