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

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ClinicalTrials.gov Identifier: NCT03661268
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Septic Shock Other: fluid chanllenge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: 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.
Other: fluid chanllenge
A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.




Primary Outcome Measures :
  1. cardiac index change [ Time Frame: 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%.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661268


Contacts
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Contact: xiang xiang, MD +86-028-61702187 xiangxiang0711@foxmail.com

Locations
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China, Sichuan
ICU of Chengdu Fifth People's Hospital Recruiting
Chengdu, Sichuan, China, 611130
Contact: xiang xiang, M.M       xiangxiang0711@foxmail.com   
Sponsors and Collaborators
Chengdu Fifth People's Hospital
Investigators
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Study Chair: wang ping, MD Chengdu Fifth People's Hospital

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Responsible Party: Chengdu Fifth People's Hospital
ClinicalTrials.gov Identifier: NCT03661268     History of Changes
Other Study ID Numbers: 2018-002(yan)-02
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation