Trial Outcomes & Findings for Hemodynamics and Extravascular Lung Water in Acute Lung Injury (NCT NCT00624650)

NCT ID: NCT00624650

Last Updated: 2019-09-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: The first seven days of treatment
• Results posted on: 2019-09-10

Participant Flow

Participant milestones

Measure	Modified FACTT (Control)	EVLW
Overall Study STARTED	17	16
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Baseline characteristics by cohort

Measure	Modified FACTT (Control) n=17 Participants	EVLW n=16 Participants	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: The first seven days of treatment

Population: The study's Principal Investigator departed the institution before analyses were conducted. OHSU will never have analyses complete for this study. The study device is no longer manufactured.

Outcome measures

Outcome data not reported

Adverse Events

Modified FACTT (Control)

Serious events: 2 serious events

Other events: 1 other events

Deaths: 2 deaths

EVLW

Serious events: 5 serious events

Other events: 2 other events

Deaths: 5 deaths

Serious adverse events

Measure	Modified FACTT (Control) n=17 participants at risk	EVLW n=16 participants at risk
Cardiac disorders Death	11.8% 2/17	31.2% 5/16

Other adverse events

Measure	Modified FACTT (Control) n=17 participants at risk	EVLW n=16 participants at risk
Renal and urinary disorders Hypernatremia	5.9% 1/17	12.5% 2/16

Additional Information

Samantha Ruimy

OHSU

Phone: 5034940724

Email: ruimy@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place