Trial Outcomes & Findings for LiDCO Monitor Study (NCT NCT01567371)

Results Overview

The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

1 Day

Results posted on

2016-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	LiDCO Rapid Monitor
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LiDCO Monitor Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LiDCO Rapid Monitor n=30 Participants
Age, Categorical <=18 years	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	21.5 years STANDARD_DEVIATION 11.018 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

Outcome measures

Outcome measures
Measure	LiDCO Rapid Monitor n=30 Participants
Difference in Pulse Pressure Variability From Baseline to Post-ANH	7.46 % variability Standard Deviation 9.149

SECONDARY outcome

Timeframe: 1 Day

The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.

Outcome measures

Outcome measures
Measure	LiDCO Rapid Monitor n=30 Participants
Difference in Stroke Volume Variability From Baseline to Post ANH.	4.46 % variability Standard Deviation 5.368

Adverse Events

LiDCO Rapid Monitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph D. Tobias, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place