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

Primary Purpose

Hypotension, Shock, Fluid Challenge

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fluid challenge
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypotension

Eligibility Criteria

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

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

Sites / Locations

  • MICU of Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Septic shock

Arm Description

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.

Outcomes

Primary Outcome Measures

Fluid Responsiveness
Increase in cardiac index ≥ 10% after fluid challenge

Secondary Outcome Measures

Full Information

First Posted
August 31, 2013
Last Updated
March 3, 2017
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01941472
Brief Title
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Shock, Fluid Challenge, Fluid Responsiveness

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Septic shock
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
fluid challenge
Intervention Description
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 Measure Information:
Title
Fluid Responsiveness
Description
Increase in cardiac index ≥ 10% after fluid challenge
Time Frame
Immediately after fluid challenge, average 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MICU of Peking Union Medical College Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29764550
Citation
Liu G, Huang H, Qin H, Du B. [Predictive value of central venous-to-arterial carbon dioxide partial pressure difference for fluid responsiveness in septic shock patients: a prospective clinical study]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 May;30(5):449-455. doi: 10.3760/cma.j.issn.2095-4352.2018.05.011. Chinese.
Results Reference
derived
PubMed Identifier
27829180
Citation
Xu B, Yang X, Wang C, Jiang W, Weng L, Hu X, Peng J, Du B. Changes of central venous oxygen saturation define fluid responsiveness in patients with septic shock: A prospective observational study. J Crit Care. 2017 Apr;38:13-19. doi: 10.1016/j.jcrc.2016.09.030. Epub 2016 Oct 19.
Results Reference
derived

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

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