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

NCT03661268 | Unknown DMC

• 1 other identifier: 2018-002(yan)-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Septic shock

EXPERIMENTAL

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

Interventions

fluid chanllenge OTHER

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

Septic shock

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chengdu Fifth People's Hospital: lead

Study Sites (1)

ICU of Chengdu Fifth People's Hospital

Chengdu, Sichuan, 611130, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• wang ping, MD

  Chengdu Fifth People's Hospital

  STUDY CHAIR

Central Study Contacts

xiang xiang, MD

CONTACT

+86-028-61702187; xiangxiang0711@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 7, 2018
• Study Start: October 1, 2018
• Primary Completion: February 28, 2021
• Study Completion: September 30, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

CN (1)