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Trial record 96 of 668 for:    CARBON DIOXIDE AND arterial

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

Tracking Information
First Submitted Date  ICMJE September 2, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date January 31, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
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%.
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Fluid Responsiveness [ Time Frame: Immediately after fluid challenge ]
Increase in cardiac index ≥ 10% after fluid challenge
Change History Complete list of historical versions of study NCT03661268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock
Official Title  ICMJE The Effect of Rapid Fluid Challenge Under Pulmonary Artery Catheter Monitoring on Physiological Indexes of Patients With Septic Shock
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Septic Shock
Intervention  ICMJE Other: fluid chanllenge
A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.
Study Arms  ICMJE 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.
Intervention: Other: fluid chanllenge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: xiang xiang, MD +86-028-61702187 xiangxiang0711@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661268
Other Study ID Numbers  ICMJE 2018-002(yan)-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chengdu Fifth People's Hospital
Study Sponsor  ICMJE Chengdu Fifth People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: wang ping, MD Chengdu Fifth People's Hospital
PRS Account Chengdu Fifth People's Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP