The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock

Fluid challenge is often carried out in septic shock patients. Its responsiveness usually requires invasive monitoring. The pulmonary artery catheter(PAC) is the most effective means of monitoring.To use non-invasive methods is very tempting. Investigators hypothesize that venous-to-arterial carbon dioxide difference,venous-to-arterial carbon oxygen difference, central venous-arterial carbon dioxide to arterial-venous oxygen content ratio and Central Venous SO2 variations provides feasible estimation on fluid responsiveness in septic shock patients.

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Other: fluid chanllenge

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiang xiang, MD; Phone Number: +86-028-61702187; Email: xiangxiang0711@foxmail.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611130
      • Recruiting
      • ICU of Chengdu Fifth People's Hospital
      • Contact: xiang xiang, M.M; Email: xiangxiang0711@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• more than 18 years old; less than 75 years old ICU patients
• Septic shock
• Monitored with pulmonary artery catheter (Swan-Ganz catheter)
• The decision of fluid challenge made by the treating physician

Exclusion Criteria:

• Evidence of fluid overload
• Pregnancy
• Recently participated in other studies
• Severe heart failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Septic shock; Patients (at least 18 years of age, no more than 75 years old) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of pulmonary artery catheter. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.

Other: fluid chanllenge; A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac index change	Fluid responsiveness: increase in CI of at least 10% after fluid challenge ;Fluid nonresponsiveness:no increase or increase in CI less than 10%.	Immediately after fluid challenge

Collaborators and Investigators

• Sponsor: Chengdu Fifth People's Hospital
• Investigators: Study Chair: wang ping, MD, Chengdu Fifth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: September 2, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 2018-002(yan)-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No