Trial Outcomes & Findings for Hemodynamic Response During Goal Directed Fluid Therapy in the OR (NCT NCT02365688)

Results Overview

Physiological parameters compared before and after fluid bolus for fluid resuscitation.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Up to 6 hours but not to exceed duration of surgical procedure

Results posted on

2017-07-18

Participant Flow

Patients meeting the inclusion and exclusion criteria were recruited in the pre-op clinic. Recruitment started on 15-AUG-2014 with ended in January 2015.

Participant milestones

Participant milestones
Measure	Initial Bolus Pre-incision Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodynamic Response During Goal Directed Fluid Therapy in the OR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Initial Bolus Pre-incision n=18 Participants Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 hours but not to exceed duration of surgical procedure

Population: Reference devices were in disagreement so the algorithm could not be verified

Physiological parameters compared before and after fluid bolus for fluid resuscitation.

Outcome measures

Outcome data not reported

Adverse Events

Pre-surgical Bolus

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pre-surgical Bolus n=18 participants at risk Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data
Surgical and medical procedures Hypertension	5.6% 1/18 • Number of events 1 • Two weeks. Consent in pre-op clinic to end of surgical procedure
Surgical and medical procedures Blood Loss	5.6% 1/18 • Number of events 1 • Two weeks. Consent in pre-op clinic to end of surgical procedure

Other adverse events

Adverse event data not reported

Additional Information

Timothy Miller MB ChB, FRCA

Duke University Medical Center, Department of Anesthesiology

Phone: (+1) 919 6819660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place