Trial Outcomes & Findings for Closed-Loop Fluid Administration System Using Hemodynamic Monitors (NCT NCT02020863)

NCT ID: NCT02020863

Last Updated: 2016-05-27

Results Overview

The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: Duration of Surgery, up to 8 hours
• Results posted on: 2016-05-27

Participant Flow

Participant milestones

Measure	Closed Loop Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration. Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.
Overall Study STARTED	40
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Closed Loop Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration. Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.
Overall Study Discovery of Metastatic disease	4
Overall Study Team chose not to place an a line	1

Baseline Characteristics

Closed-Loop Fluid Administration System Using Hemodynamic Monitors

Baseline characteristics by cohort

Measure	Closed Loop n=35 Participants Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration. Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Age, Continuous	61.6 years STANDARD_DEVIATION 12.8 • n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants
Region of Enrollment United States	35 participants n=93 Participants
Specific Surgical procedure Whipple	9 participants n=93 Participants
Specific Surgical procedure Whipple + additional	8 participants n=93 Participants
Specific Surgical procedure Distal pancreatectomy	5 participants n=93 Participants
Specific Surgical procedure Liver resection	10 participants n=93 Participants
Specific Surgical procedure Complex cholecystectomy	3 participants n=93 Participants
ASA Physical Status patient classification 2	1 participants n=93 Participants
ASA Physical Status patient classification 3	28 participants n=93 Participants
ASA Physical Status patient classification 4	6 participants n=93 Participants
Stroke Volume Index	44 ml per meter-squared STANDARD_DEVIATION 10 • n=93 Participants

PRIMARY outcome

Timeframe: Duration of Surgery, up to 8 hours

Population: Closed Loop Study population at Stroke Volume Variation (SVV) ≤12%

The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.

Outcome measures

Measure

Closed Loop n=40 Participants Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration. Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.

Fluid Status During Surgery

95 percentage of case time Standard Deviation 6

Adverse Events

Closed Loop

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

Maxime Cannesson, PhD

University of California, Irvine Health

Phone: 714- 456-5059

Email: mcanness@uci.edu

Results disclosure agreements

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