NCT02083757

Brief Summary

Our goal was to study the feasibility of predicting fluid responsiveness by transcutaneous partial pressure of oxygen (PtcO2) in the critically ill patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.6 years

First QC Date

March 7, 2014

Last Update Submit

May 26, 2015

Conditions

Keywords

Fluid responsiveness; Passive leg raising

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

    Noninvasive bioreactance CO monitoring was obtained using the NICOM system (Cheetah Medical, Portland, OR) with four double-electrode stickers placed on the chest wall.

    30min

Study Arms (2)

Resp

Fluid responsiveness is defined as a change of stroke volume stroke volume ≥ 10% after 250 ml rapid saline infusion in 10 minutes.

Nonresp

Fluid responsiveness is defined as a change of stroke volume stroke volume \< 10% after 250 ml rapid saline infusion in 10 minutes.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients for whom the attending physician decided to perform a fluid challenge or presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion for less than 24 hours were eligible to participate in the study.

You may qualify if:

  • clinical signs of inadequate tissue perfusion defined as systolic blood pressure \< 90 mm Hg or a decrease \> 40 mmHg in previously hypertensive patients or the need for vasopressive drugs (dopamine \> 5 ug/kg/min or norepinephrine); urine output \< 0.5 ml/kg/hr for 2 hrs; tachycardia; presence of skin mottling.

You may not qualify if:

  • pregnancy, age of less than 18 years, contraindication to passive leg raising test, cardiac arrhythmias, cardiogenic pulmonary edema, the presence of abdominal compartment syndrome and refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

  • Xu J, Peng X, Pan C, Cai S, Zhang X, Xue M, Yang Y, Qiu H. Fluid responsiveness predicted by transcutaneous partial pressure of oxygen in patients with circulatory failure: a prospective study. Ann Intensive Care. 2017 Dec;7(1):56. doi: 10.1186/s13613-017-0279-0. Epub 2017 May 23.

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongda Hospital

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations