Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01941472
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : March 3, 2017
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
Bin Du, Peking Union Medical College Hospital

Brief Summary:
Fluid challenge is often carried out in critical ill patients. Its responsiveness usually requires invasive monitoring. To use non-invasive methods is very tempting. Investigators hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations provide feasible estimation on fluid responsiveness in critical ill patients.

Condition or disease Intervention/treatment
Hypotension Shock Fluid Challenge Fluid Responsiveness Other: fluid challenge

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : September 2013
Primary Completion Date : December 2015
Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Septic shock
Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. 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 challenge
A bag of 500ml of normal saline or 4% gelatin (Gelofusine, B. Braun Medical (Suzhou) Company Limited, Suzhou, China) 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.

Primary Outcome Measures :
  1. Fluid Responsiveness [ Time Frame: Immediately after fluid challenge, average 5 minutes ]
    Increase in cardiac index ≥ 10% after fluid challenge

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years and older ICU patients;
  • Septic shock;
  • Monitored with PICCO or Swan-Ganz catheter;
  • The decision of fluid challenge made by the treating physician;

Exclusion Criteria:

  • Evidence of fluid overload;
  • Pregnancy

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 identifier (NCT number): NCT01941472

China, Beijing
MICU of Peking Union Medical College Hospital
Peking, Beijing, China, 100000
Sponsors and Collaborators
Peking Union Medical College Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bin Du, Director of Medical ICU, Peking Union Medical College Hospital Identifier: NCT01941472     History of Changes
Other Study ID Numbers: MICU2013-1
First Posted: September 13, 2013    Key Record Dates
Results First Posted: March 3, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases