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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03661268
• Other study ID #: 2018-002(yan)-02
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2021
• Source: Chengdu Fifth People's Hospital
• Contact: xiang xiang, MD
• Phone: +86-028-61702187
• Email: xiangxiang0711[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
China	ICU of Chengdu Fifth People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Fifth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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