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

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

fluid chanllenge

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ICU of Chengdu Fifth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Septic shock

Arm Description

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Full Information

NCT ID

NCT03661268

First Posted

September 2, 2018

Last Updated

January 27, 2021

Sponsor

Chengdu Fifth People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03661268

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

February 28, 2021 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu Fifth People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Septic shock

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

fluid chanllenge

Intervention Description

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

Primary Outcome Measure Information:

Title

cardiac index change

Description

Fluid responsiveness: increase in CI of at least 10% after fluid challenge ;Fluid nonresponsiveness:no increase or increase in CI less than 10%.

Time Frame

Immediately after fluid challenge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xiang xiang, MD

Phone

+86-028-61702187

xiangxiang0711@foxmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

wang ping, MD

Organizational Affiliation

Chengdu Fifth People's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

ICU of Chengdu Fifth People's Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

611130

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

xiang xiang, M.M

xiangxiang0711@foxmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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