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

NCT ID: NCT01941472

Last Updated: 2017-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension Shock Fluid Challenge Fluid Responsiveness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

fluid challenge

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bin Du

Director of Medical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MICU of Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29764550 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27829180 (View on PubMed)

Other Identifiers

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MICU2013-1

Identifier Type: -

Identifier Source: org_study_id

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