Trial Outcomes & Findings for Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness (NCT NCT01941472)

Results Overview

Increase in cardiac index ≥ 10% after fluid challenge

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Immediately after fluid challenge, average 5 minutes

Results posted on

2017-04-04

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Septic Shock n=40 Participants 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.
Age, Continuous	60 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
acute physiology and chronic health evaluation(APACHE) II score	27 units on a scale STANDARD_DEVIATION 6 • n=5 Participants

Timeframe: Immediately after fluid challenge, average 5 minutes

Increase in cardiac index ≥ 10% after fluid challenge

Outcome measures
Measure	Septic Shock n=40 Participants 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.
Fluid Responsiveness	18 Participants

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Septic Shock n=40 participants at risk 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.
Blood and lymphatic system disorders blood loss	100.0% 40/40 • Number of events 40

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