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

Not Applicable

• Conditions: Abdominal Tumor; Abdominal Infection
• Interventions: Other: conventional fluid therapy; Other: standardized fluid therapy

• Registration Number: NCT02977429
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-09
• Study First Submitted QC: 2016-11-27
• Last Update Submitted: 2016-11-27
• Study First Posted: 2016-11-30
• Last Update Posted: 2016-11-30
• Primary Completion: 2018-01
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard group	conventional fluid therapy	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"
control group	standardized fluid therapy	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"

Primary Outcome Measures

Name	Time	Method
The change of Pcv-aCO2	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

Name	Time	Method
The 28 day mortality in different groups	Twenty-eighth days after admission	Collect the index of 28 day mortality(%) of patients in different groups.
The hospitalization course in different groups	Twenty-eighth days after admission	Collect the index of hospitalization course(days) of patients in different groups.
The treatment success rate in different groups	Twenty-eighth days after admission	Collect the index of treatment success rate(%) of patients in different groups.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China