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Clinical Trials/NCT02977429
NCT02977429UnknownNot Applicable

Clinical Study of Central Venous-to-Arterial Carbon Dioxide Difference(Pcv-aCO2) in the Evaluation of Fluid Therapy for Postoperative Patients With Abdominal Cancer

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country150 target enrollmentStarted: October 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
1
Primary Endpoint
The change of Pcv-aCO2
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The 28 day mortality in different groups(Twenty-eighth days after admission)
  • The hospitalization course in different groups(Twenty-eighth days after admission)
  • The treatment success rate in different groups(Twenty-eighth days after admission)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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