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

Not Applicable

• Conditions: Septic Shock
• Interventions: Other: fluid chanllenge

• Registration Number: NCT03661268
• Lead Sponsor: Chengdu Fifth People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-02
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28
• Primary Completion: 2021-02-28
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Septic shock	fluid chanllenge	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

ICU of Chengdu Fifth People's Hospital; 🇨🇳 Chengdu, Sichuan, China