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

NCT ID: NCT03661268

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-09-30

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.

Conditions

Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fluid chanllenge

Intervention Type: OTHER

A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.

Interventions

fluid chanllenge

A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Fifth People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wang ping, MD

Role: STUDY_CHAIR

Chengdu Fifth People's Hospital

Locations

ICU of Chengdu Fifth People's Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiang xiang, MD

Role: CONTACT

xiangxiang0711@foxmail.com

+86-028-61702187

Facility Contacts

xiang xiang, M.M

Role: primary

xiangxiang0711@foxmail.com

Other Identifiers

2018-002(yan)-02

Identifier Type: -

Identifier Source: org_study_id