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

NCT02977429 | Unknown DMC

• 1 other identifier: bc2016032
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Tumor; Abdominal Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The change of Pcv-aCO2

  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 Outcomes (3)

• The treatment success rate in different groups

  Twenty-eighth days after admission

• The 28 day mortality in different groups

  Twenty-eighth days after admission

• The hospitalization course in different groups

  Twenty-eighth days after admission

Other Outcomes (6)

• The change of Central Venous Oxygen Saturation (ScvO2)

  fluid resuscitation for 6 hours, 12 hours and 24 hours

• The change of hemoglobin (Hb)

  fluid resuscitation for 6 hours, 12 hours and 24 hours

• The change of blood lactic acid (Lac)

  fluid resuscitation for 6 hours, 12 hours and 24 hours

Study Arms (2)

standard group

ACTIVE COMPARATOR

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"

Other: conventional fluid therapy

control group

SHAM COMPARATOR

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"

Other: standardized fluid therapy

Interventions

standardized fluid therapy OTHER

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

Also known as: Therapeutic effect of fluid resuscitation

control group

conventional fluid therapy OTHER

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

standard group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 21034476 BACKGROUND

• 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.

  PMID: 20179283 BACKGROUND

• 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.

  PMID: 19854541 BACKGROUND

• 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.

  PMID: 21078769 BACKGROUND

MeSH Terms

Conditions

Abdominal Neoplasms; Intraabdominal Infections; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Infections

Study Officials

• Wanhua Wang, director

  Tianjin Medical University Cancer Institute and Hospital

  STUDY DIRECTOR

Central Study Contacts

Yang Yang, physician

CONTACT

022-23340123; yyicu3021@126.com

Yang Lu, physician

CONTACT

022-23340123; Yang_lu1299@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: November 30, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 30, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)